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ISO standards to know before buying your medical device!  

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Health is a real issue for society. It requires quality health care and medical devices. This is where ISO standards come in. They are a guarantee of quality and reliability. If you need to buy medical equipment for a health care facility, you certainly have requirements in terms of ISO standards. In any case, this should be the case! 


What is the ISO standard? 


ISO stands for International Organisation for Standardisation. This organisation sets international standards on a voluntary basis. 


Why ISO standards for medical devices? 


ISO standards are the assurance of reliable medical devices for quality healthcare. This is also our goal at XML MED - specialist in disposable protective equipment (PPE) for the medical sector. 


ISO standards medical device


What are the ISO standards for medical devices? 


We offer you an overview of the ISO standards for the purchase of a medical device. This overview is based on the standards that you can regularly find on our products, i.e. disposable personal protective equipment for the healthcare sector. These standards may be useful to you when making your purchasing decision. 


ISO 13485 standard 

The ISO 13485 standard ensures a quality management system for medical devices


It is the leading ISO standard for medical devices. If there is one standard you should pay attention to when purchasing, this is it. 


There is also the 9001 standard which defines the criteria for a quality management system more generally. 

ISO 10993 standard

ISO 10993 provides a process for the biological evaluation of medical devices


It has several parts. It is possible that only one of these parts is concerned. It is therefore interesting to know them. 


The different parts of ISO 10993 : 


ISO 10993-1

Assessment and testing within a risk management process

ISO 10993-2

Animal protection requirements

ISO 10993-3

Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-4

Choice of tests for blood interactions

ISO 10993-5

In vitro cytotoxicity tests

ISO 10993-6

Tests on local effects after implantation

ISO 10993-7

Ethylene oxide sterilisation residues

ISO 10993-8

Selection and qualification of reference materials used for bioassays

ISO 10993-9

Framework for the identification and quantification of potential degradation products

ISO 10993-10

Skin sensitisation tests

ISO 10993-11

Systemic toxicity tests

ISO 10993-12

Preparation of samples and reference materials

ISO 10993-13

Identification and quantification of degradation products of polymer-based medical devices

ISO 10993-14

Identification and quantification of ceramic degradation products

ISO 10993-15

Identification and quantification of degradation products from metals and alloys

ISO 10993-16

Design of toxicokinetic studies of degradation products and leachables

ISO 10993-17

Establishment of allowable limits for leachable substances

ISO 10993-18

Chemical characterisation of medical device materials within a risk management process

ISO 10993-19

Physicochemical, morphological and topographical characterisation of materials

ISO 10993-20

Principles and methods for immunotoxicology testing of medical devices

ISO 10993-22

Guidelines on nanomaterials

ISO 10993-23

Irritation tests


ISO 14971 standard

ISO 14971 ensures a risk management process for medical devices


ISO 16604 standard

The ISO 16604 standard provides a process for measuring the resistance of protective clothing to blood penetration. 


ISO 21420 standard

ISO 21420 defines the general requirements and test methods for the creation of the protective glove


ISO 374 standard

ISO 374 specifies the requirements for protective gloves against hazardous chemicals and micro-organisms


The different parts of ISO 374 : 

ISO 374-1

Terminology and performance requirements for chemical hazards

ISO 374-2

Determination of penetration resistance

ISO 374-4

Determination of resistance to chemical degradation

ISO 374-5

Terminology and performance requirements for risks against micro-organisms

Please note that the standards and their parts may be affected by revisions of the standards. 

ISO standards medical device


How to read and understand an ISO standard? 


What do the numbers after the colon mean? 

For example: ISO 13485:2016. 

The numbers after the colon indicate the date of creation or revision of the standard. Here, 2016. Standards are reviewed every 5 years. 


What do the numbers after the dash mean? 

For example: ISO 10993-10:2021. 

The number(s) after the hyphen correspond(s) to the part of the standard concerned. Here, the tenth. Standard 10993 deals with the biological evaluation of medical devices. Part 10 of this standard deals specifically with skin sensitisation testing. 


What do the letters EN stand for in front of the ISO standard? 

For example: EN ISO 14971:2012. 

ISO gives information on the standardisation body while EN gives information on the area of applicability. The ISO standard is internationally recognised, the EN standard is European. The two pieces of information can be combined.

Now you know more about ISO medical device standards. You understand their importance and the impact they have on healthcare. 


XML MED could certainly be of interest to you for the purchase of your disposable PPE. Do not hesitate to discover our products, they all comply with European standards. 


ISO standards medical device

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