ISO standards to know before buying your medical device!
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 medical device 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.
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 :
Assessment and testing within a risk management process
Animal protection requirements
Tests for genotoxicity, carcinogenicity and reproductive toxicity
Choice of tests for blood interactions
In vitro cytotoxicity tests
Tests on local effects after implantation
Ethylene oxide sterilisation residues
Selection and qualification of reference materials used for bioassays
Framework for the identification and quantification of potential degradation products
Skin sensitisation tests
Systemic toxicity tests
Preparation of samples and reference materials
Identification and quantification of degradation products of polymer-based medical devices
Identification and quantification of ceramic degradation products
Identification and quantification of degradation products from metals and alloys
Design of toxicokinetic studies of degradation products and leachables
Establishment of allowable limits for leachable substances
Chemical characterisation of medical device materials within a risk management process
Physicochemical, morphological and topographical characterisation of materials
Principles and methods for immunotoxicology testing of medical devices
Guidelines on nanomaterials
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 :
Terminology and performance requirements for chemical hazards
Determination of penetration resistance
Determination of resistance to chemical degradation
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.
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.