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Elevating Healthcare: ISO and BIS Standards Unveiled for Medical Devices and IVDs

In the ever-evolving landscape of medical technology, manufacturers and regulatory bodies alike rely on stringent standards to ensure patient safety and product effectiveness. ISO and BIS standards serve as the guiding stars, providing a roadmap for compliance in the realm of medical devices and In Vitro Diagnostic (IVD) products. In this insightful guide, we embark on a journey through the intricacies of these standards, exploring how they shape the industry and promote excellence in healthcare.

In light of the recent and sweeping changes in global medical device and In Vitro Diagnostic (IVD) regulations, adherence to applicable standards has emerged as an imperative for manufacturers and stakeholders across the industry. With the enforcement of these new regulations, both product-specific and industry-specific standards have transitioned from being optional to becoming a mandatory compass that guides the development, production, and evaluation of medical devices and IVDs. These standards not only serve as essential compliance measures but also play a pivotal role in shaping the landscape of healthcare, ensuring the safety, quality, and effectiveness of the products that impact countless lives worldwide.

The transformation in regulatory landscape necessitates a comprehensive understanding of the standards landscape, their implications, and the benefits they bring to the healthcare ecosystem. In this exploration, we embark on a journey to delve deeper into the significance of adhering to these standards, the key standards governing various aspects of medical devices and IVDs, and the broader implications of this paradigm shift in healthcare regulation. Join us as we navigate the intricate web of standards that underpin the future of medical technology.

Applicable Regulations for Medical Devices and IVDs

INDIA

MDR 2017

Medical Device Rules, 2017

EUROPE

EU MDR 2017/745

EU IVDR 2017/746

Medical Device Regulation 2017/745

In-Vitro Diagnostic regulation 2017/746

USA

21 CFR Part 800

Title-21, Chapter-I, Subchapter-H, Part 800

UK

UK MDR 2002

Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)



STANDARDS FOR MEDICAL DEVICES

S No

Standard

Description

Purpose

1.       

IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Electrical Safety

2.       

IEC 60601-1-10

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers

Physiologic Closed-Loop Controllers

3.       

IEC 60601-1-11

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environments

Home Healthcare Equipment Safety

4.       

IEC 60601-1-12

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Emergency Medical Services Equipment Safety

5.       

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

Electromagnetic Compatibility

6.       

IEC 60601-1-4

Medical electrical equipment - Part 1-4: General requirements for basic safety and essential performance - Collateral standard: Programmable electrical medical systems

Programmable Medical Systems

7.       

IEC 60601-1-6

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Usability Requirements

8.       

IEC 60601-1-8

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Alarm Systems in Medical Equipment

9.       

IEC 60601-1-9

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design

Environmentally Conscious Design

10.     

IEC 60601-2

Particular requirements for the safety of specific types of medical electrical equipment

Electrical Safety

11.     

IEC 60601-2-2

Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories

High-Frequency Surgical Equipment Safety

12.     

IEC 60601-2-24

Particular requirements for the basic safety and essential performance of infusion pumps and controllers

Infusion Pumps Safety

13.     

IEC 60601-2-25

Particular requirements for the basic safety and essential performance of electrocardiographs

Electrocardiograph Safety

14.     

IEC 60601-2-27

Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Electrocardiographic Monitoring Equipment Safety

15.     

IEC 60601-2-28

Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

X-ray Tube Assemblies Safety

16.     

IEC 60601-2-36

Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment

Dental Extraoral X-ray Equipment Safety

17.     

IEC 60601-2-37

Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Ultrasonic Medical Diagnostic and Monitoring Equipment Safety

18.     

IEC 60601-2-38

Particular requirements for the basic safety and essential performance of electromyography equipment

Electromyography Equipment Safety

19.     

IEC 60601-2-39

Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment

Peritoneal Dialysis Equipment Safety

20.     

IEC 60601-2-4

Particular requirements for the basic safety and essential performance of cardiac defibrillators

Cardiac Defibrillator Safety

21.     

IEC 60601-2-40

Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Electromyographs and Evoked Response Equipment Safety

22.     

IEC 60601-2-42

Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy equipment

Extracorporeal Lithotripsy Equipment Safety

23.     

IEC 60601-2-43

Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

Surgical and Diagnostic Luminaires Safety

24.     

IEC 60601-2-44

Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Computed Tomography X-ray Equipment Safety

25.     

IEC 60601-2-49

Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Multifunction Patient Monitoring Equipment Safety

26.     

IEC 60601-2-51

Particular requirements for the basic safety and essential performance of recording and analysis equipment

Recording and Analysis Equipment Safety

27.     

IEC 60601-2-52

Particular requirements for the basic safety and essential performance of medical beds

Medical Bed Safety

28.     

IEC 60601-2-56

Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement

Clinical Thermometers Safety

29.     

IEC 60601-2-57

Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use

Non-Laser Light Source Equipment Safety

30.     

IEC 60601-2-58

Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices

Lens Removal and Vitrectomy Devices Safety

31.     

IEC 60601-2-61

Particular requirements for basic safety and essential performance of pulse oximeter equipment for medical use

Pulse Oximeter Equipment Safety

32.     

IEC 60601-2-66

Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Hearing Instruments Safety

33.     

IEC 60601-2-70

Particular requirements for the basic safety and essential performance of sleep apnea breathing therapy equipment

Sleep Apnea Breathing Therapy Equipment Safety

34.     

IEC 60601-2-8

Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Therapeutic X-ray Equipment Safety

35.     

IEC 61508

Functional safety of electrical/electronic/programmable electronic safety-related systems

Functional Safety

36.     

IEC 62304

Medical device software - Software life cycle processes

Software Development

37.     

EC 62304-1

Medical device software - Part 1: Framework for the life cycle processes of medical device software

Software Life Cycle Framework

38.     

IEC 62304-2

Medical devices - Part 2: Validation of usability engineering processes

Validation of Usability Engineering Processes

39.     

IEC 62304-3

Medical devices - Part 3: Validation of software development processes for medical device software

Validation of Software Development Processes

40.     

IEC 62304-4

Medical devices - Part 4: Validation of software requirements

Validation of Software Requirements

41.     

IEC 62304-5

Medical devices - Part 5: Validation of software architectural design

Validation of Software Architectural Design

42.     

IEC 62304-6

Medical devices - Part 6: Validation of software systems

Validation of Software Systems

43.     

IEC 62304-7

Medical device software - Part 7: Application guidance - Software maintenance process

Application Guidance for Software Maintenance Process

44.     

IEC 62304-8

Medical device software - Part 8: Application guidance - Software risk management

Application Guidance for Software Risk Management

45.     

IEC 62353

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Electrical Testing

46.     

IEC 62366

Medical devices - Application of usability engineering to medical devices

Usability Engineering

47.     

IEC 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices

Usability Engineering Application

48.     

IEC 62366-2

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

Usability Engineering Application Guidance

49.     

IEC 62366-3

Medical devices - Part 3: Guidance on the application of usability engineering to medical devices in development

Usability Engineering Application Guidance in Development

50.     

IEC 62366-4

Medical devices - Part 4: Application of usability engineering to medical devices that include software

Usability Engineering Application to Devices with Software

51.     

IEC 62366-5

Medical devices - Part 5: Process for usability specifications

Usability Specifications Process

52.     

IEC 62366-6

Medical devices - Part 6: Usability evaluation methods

Usability Evaluation Methods

53.     

IEC 62366-7

Medical devices - Part 7: Usability evaluation of medical software

Usability Evaluation of Medical Software

54.     

IEC 62366-8

Medical devices - Part 8: Usability data exchange

Usability Data Exchange

55.     

IEC/TR 62366-2

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices (Technical Report)

Usability Engineering Application Guidance (Technical Report)

56.     

ISO 10012

Measurement management systems - Requirements for measurement processes and measuring equipment

Measurement Management

57.     

ISO 10013

Guidelines for quality management system documentation

Quality Management System Documentation

58.     

ISO 10993

Biological evaluation of medical devices

Biological Safety

59.     

ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Biological Evaluation Risk Management

60.     

ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

Allowable Limits for Leachable Substances

61.     

ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of materials

Chemical Characterization of Materials

62.     

ISO 10993-19

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

Characterization of Materials

63.     

ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements

Animal Welfare in Biological Evaluation

64.     

ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Genotoxicity, Carcinogenicity, and Reproductive Toxicity Testing

65.     

ISO 11135

Sterilization of health care products - Ethylene oxide

Ethylene Oxide Sterilization

66.     

ISO 11137

Sterilization of health care products - Radiation

Sterilization

67.     

ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Radiation Sterilization Process

68.     

ISO 11139

Sterilization of health care products - Validation of the performance of sterilizers

Sterilizer Performance Validation

69.     

ISO 11140

Sterilization of health care products - Chemical indicators - Part 1: General requirements

Chemical Indicators for Sterilization

70.     

ISO 1135

Transfusion equipment for medical use

Transfusion Equipment

71.     

ISO 11607

Packaging for terminally sterilized medical devices

Packaging

72.     

ISO 11608

Needle-based injection systems for medical use - Requirements and test methods

Needle-based Injection Systems

73.     

ISO 11737

Sterilization of medical devices - Microbiological methods

Microbiological Methods for Sterilization

74.     

ISO 11737-1

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

Microbiological Population Determination

75.     

ISO 11737-2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process

Sterility Testing in Sterilization Validation

76.     

ISO 11737-3

Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data

Bioburden Data Evaluation

77.     

ISO 11979

Ophthalmic implants - Intraocular lenses

Intraocular Lenses

78.     

ISO 1302

Geometrical Product Specifications (GPS) - Indication of surface texture in technical product documentation

Indication of Surface Texture

79.     

ISO 13408

Aseptic processing of health care products

Aseptic Processing

80.     

ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements

General Requirements for Aseptic Processing

81.     

ISO 13408-2

Aseptic processing of health care products - Part 2: Sterilization-in-place

Sterilization-in-place for Aseptic Processing

82.     

ISO 13485

Quality management systems - Medical devices - Requirements for regulatory purposes

Quality Management

83.     

ISO 13732

Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces

Assessment of Human Responses to Hot Surfaces

84.     

ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

Clinical Investigation

85.     

ISO 14160

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation, and routine control of a sterilization process for medical devices

Liquid Chemical Sterilization Agents

86.     

ISO 14161

Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results

Biological Indicators for Sterilization

87.     

ISO 14385

Sterile single-use intravascular catheters - Particular requirements for intravascular catheters with enhanced features for guidewire access in a sterile field

Intravascular Catheters with Enhanced Features

88.     

ISO 14630

Non-active surgical implants - General requirements

Non-active Surgical Implants

89.     

ISO 14708

Implants for surgery - Active implantable medical devices

Active Implantable Medical Devices

90.     

ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process

Sterilization Process Control

91.     

ISO 14971

Medical devices - Application of risk management to medical devices

Risk Management

92.     

ISO 15001

Medical electrical equipment - Guidance on the application of usability engineering to medical electrical equipment and medical electrical systems

Usability Engineering Guidance

93.     

ISO 15004

Ophthalmic instruments - Fundamental requirements and test methods for light hazard protection

Light Hazard Protection for Ophthalmic Instruments

94.     

ISO 15012

Sterilization of health care products - Biological and chemical indicators - Test equipment

Test Equipment for Biological and Chemical Indicators

95.     

ISO 15189

Medical laboratories - Requirements for quality and competence

Laboratory Quality

96.     

ISO 15223-1

Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied

Labeling Symbols

97.     

ISO 15223-2

Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 2: Symbol development, selection, and validation

Symbol Development and Validation

98.     

ISO 16061

Cardiovascular implants - Tubular vascular grafts

Tubular Vascular Grafts

99.     

ISO 17025

General requirements for the competence of testing and calibration laboratories

Testing and Calibration Competence

100.    

ISO 17664

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

Manufacturer's Instructions for Resterilizable Devices

101.    

ISO 17664-2

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

Guidance on the Application of Moist Heat Sterilization

102.    

ISO 17665

Sterilization of health care products - Moist heat

Moist Heat Sterilization

103.    

ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

Moist Heat Sterilization Process Requirements

104.    

ISO 18562

Biocompatibility evaluation of breathing gas pathways in healthcare applications

Biocompatibility Evaluation

105.    

ISO 18562-1

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing

Biocompatibility Evaluation of Breathing Gas Pathways

106.    

ISO 20342

Dentistry - Medical devices for dentistry - Articulating paper

Articulating Paper for Dentistry

107.    

ISO 21929

Cardiovascular implants - Tubular vascular prostheses

Tubular Vascular Prostheses

108.    

ISO 5840

Cardiovascular implants - Cardiac valve prostheses

Cardiac Valve Prostheses

109.    

ISO 5841

Implants for cardiac pacing - Pacemakers

Cardiac Pacemakers

110.    

ISO 80601-2-55

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Respiratory Gas Monitors

111.    

ISO 80601-2-74

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Respiratory Humidifying Equipment Safety

112.    

ISO 20417

Medical devices — Information to be supplied by the manufacturer

Information to be supplied by the manufacturer

113.    

ISO/TR 20416

 

Medical devices — Post-market surveillance for manufacturers

 

Post market surveillance




STANDARDS FOR IN-VITRO DIAGNOSTIC DEVICES

S No

Standard

Description

Purpose

1.       

ISO 15189

Medical laboratories - Requirements for quality and competence

requirements for the competence and quality of medical laboratories, including those performing diagnostic testing with IVD devices

2.       

ISO 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

requirements for the accuracy and reliability of blood-glucose monitoring systems used for self-testing by individuals managing diabetes

3.       

ISO 22870

Point-of-care testing (POCT) - Requirements for quality and competence

quality and competence requirements for healthcare facilities and professionals performing point-of-care testing using IVD devices

4.       

ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

terms and requirements for the labeling of IVD devices to ensure clear and accurate information is provided to users

5.       

ISO 23640

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

principles for evaluating the stability of in vitro diagnostic reagents, ensuring their reliability and performance over time.


Navigating the world of medical device and IVD standards can be complex. We invite you to engage with us by commenting and asking questions. If you have any inquiries, seek clarification, or require further insights on specific standards or regulatory aspects, please don't hesitate to reach out. Our dedicated team of experts is here to assist you on your journey to compliance, ensuring that your innovations in medical technology contribute positively to the well-being of humanity. Your comments and questions are invaluable, and we look forward to addressing them comprehensively.


EMI/EMC (Electromagnetic compatibility Immunity (EMI)/ Electromagnetic compatibility (EMC) Standards


IEC 61326-1

Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements

IEC 61000-3-2

Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)

IEC 61000-3-3

Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection

IEC 61000-3-11

Electromagnetic compatibility (EMC) – Part 3- 11: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low- voltage supply systems — Equipment with rated current <= 75 A and subject to conditional connection

IEC 61000-3-12

Electromagnetic compatibility (EMC) – Part 3- 12: Limits – Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and <= 75 A per phase

IEC 61000-6-1

Electromagnetic compatibility (EMC) – Part 6-1: Generic standards – Immunity for residential, commercial and light-industrial environments I

IEC 61000-6-2

Electromagnetic compatibility (EMC) – Part 6-2: Generic standards – Immunity for industrial environments

IEC 61000-6-3

Electromagnetic compatibility (EMC) – Part 6-3: Generic standards – Emission standard for residential, commercial and light-industrial environments

IEC 61000-6-4

Electromagnetic compatibility (EMC) – Part 6-4: Generic standards – Emission standard for industrial environments

IEC 61000-6-5

Electromagnetic compatibility (EMC) – Part 6-5: Generic standards – Immunity for equipment used in power station and substation environment

IEC 61000-4-2

Electromagnetic compatibility (EMC) – Part 4-2: Generic standards – Testing and measurement techniques – Electrostatic discharge immunity test

IEC 61000-4-4

Electromagnetic compatibility (EMC) – Part 4-4: Generic standards – Testing and measurement techniques – Electrical fast transient/burst immunity test

IEC 61000-4-5

Electromagnetic compatibility (EMC) – Part 4-5: Generic standards – Testing and measurement techniques – Surge immunity test



Standards for Hospital equipment – Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.

 ISO 10282

Single-use sterile rubber surgical gloves — Specification

 ISO 11193-1

Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution

 ISO 11193-2

Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)

 ISO 21171

Medical gloves — Determination of removable surface powder

 ISO 22609

Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

 ISO 22610

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

 ISO 22882

Castors and wheels — Requirements for castors for hospital beds

 IEC/TR 60601-4-1:

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

 IEC 60601-2-52

Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Amendment 1

 IEC 60601-2-52:2009/Cor 1

Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Technical Corrigendum 1

 IEC 60601-2-31

Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

 IEC/DIS 80601-2-52

Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

 IEC/DIS 80601-2-89

Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

Newly Added Standards in 2024 for Medical Devices


ISO 10394:2023

Dentistry — Designation system for supernumerary teeth

ISO 23402-3:2024

Dentistry — Portable dental equipment for use in non‐permanent healthcare environment

ISO 5832-1:2024

Implants for surgery - Metallic materials -Part 1: Wrought stainless steel

ISO 5832-4:2024

Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy

ISO 5832-7:2024

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel molybdenumiron alloy

ISO 8637-2:2024

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 23500-3:2024

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

ISO 23500-4:2024

Preparation and quality management of fluids for haemodialysis and related therapies -Part 4: Concentrates for haemodialysis and related therapies

ISO 23500-5:2024

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

ISO 7151:2024

Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods

ISO 16840-2:2018/Amd1:2024

Wheelchair seating - Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity - Amendment 1: Updates and addition of new Annex covering alternatively sized cushions

ISO 16840-10:2021/Amd 1:2024

Wheelchair seating - Part 10: Resistance to ignition of postural support devices -Requirements and test method -Amendment 1: Amended with additional Annexes and test method XZ

ISO/TS 16840-15:2024

Wheelchair seating - Part 15: Selection, placement and fixation of flexible postural support devices in seating

ISO 16021:2024

Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers

ISO 21860:2020

Health Informatics — Reference standards portfolio (RSP) — Clinical imaging

ISO 18209-1:2024

Biotechnology - Biobanking of parasites - Part 1: Helminths

ISO/IEC 15421:2010

Information technology -Automatic identification and data capture techniques - Bar code master test specifications



Before Applying standards kindly check their latest versions, we have tried each possible way to provided updated contenet till date, if you feel any information is outdated feel free to let us know sciencearena[dot]in[at]gmail[dot]com

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