With this article, we want to point out that standards are important to consider when developing or producing medical devices, and therefore highlight some of these standards. AMB is certified according to ISO 9001 and ISO 13485 (as well as ISO 14001), and discussions about quality management and risk management are an important part in connection with customers’ product development or when we will start producing a product. The standards thus provide a common basis for conversations with customers and employees and ensure quality-assured production and products.
Why are standards needed?
We love or hate standards and norms depending on one’s position or attitude. But how do standards really arise? And what are the benefits?
Standards create uniform and transparent routines that we can agree on. It is in everyone’s interest to avoid misunderstandings and to avoid reinventing the wheel every time. Standards give manufacturers clarity in what applies and they provide legal certainty.
If a medical device does not work properly or does not work at all, this can have far-reaching consequences. To prevent this, specific standards and associated approval procedures were developed. In the following, the term standard in medical technology and the general purpose of standards are defined. A distinction is also made between process and quality standards. We comment on some of the standards for manufacturers of medical devices. But of course there are many more that can be important in different contexts.
Benefits of standards
The fact that there are standards is good for players in all industries. The main benefits are:
- Uniform standards and verifiable standards provide manufacturers with information on what applies and ultimately give them a competitive advantage.
- The reference to standards in contracts provides legal certainty.
- Standards promote safety; for example by CE marking as part of the approval.
- The risks regarding product liability are reduced.
- The time and costs for documentation of quality assurance are reduced.
What are standards and how are they developed?
Standards are documented knowledge from prominent actors in industry, business and society and which are prepared in collaboration between them. These standards represent the level of technology that manufacturers of medical devices must take into account when developing, manufacturing and using the products. Adapting to or complying with standards is not always mandatory, but it is not uncommon for laws and regulations to require compliance.
ISO is an internatinal voluntary organization whose members are recognized authorities on standards, each one representing one country. Members meet annually at a General Assembly to discuss the strategic objectives of ISO. The organization is coordinated by a central secretariat based in Geneva.
The technical management board is responsible for more than 250 technical committees, who develop the ISO standards. ISO has 165 national members and national bodies who are considered the most representative standards body in each country.
ISO describes the devolopment of standars as follow:
Like a symphony, it takes a lot of people working together to develop a standard. ISO’s role is similar to that of a conductor, while the orchestra is made up of independent technical experts nominated by our members.
They begin the process with the development of a draft that meets a market need within a specific area. This is then shared for commenting and further discussion.
The voting process is the key to consensus. If that’s achieved then the draft is on its way to becoming an ISO standard. If agreement isn’t reached then the draft will be modified further, and voted on again.
From first proposal to final publication, developing a standard usually takes about 3 years.
- Idea / Suggestion
- Decision on start-up
- Project start
- Preparation in working group
- Anchoring in committee
- Public referral
- Revision of proposals
- Final vote
- Establishment and publication
Consequently, a standard is a technical description that is accessible to all and that is based on coordinated results from science, practice and technology. Standards are approved by a recognized organization nationally or internationally as eg by:
EU MDR and IVDR
In medical technology, standards serve, among other things, to define the minimum requirements for medical technology products. Standards that are of fundamental importance to the field of medical technology have been developed through harmonization within the EU and have been governed since 26 May 2021 by the Medical Device Regulation (MDR).
However, the previous Directive 98/79 / EC on in vitro diagnostics has not been transposed into the Regulation on Medical Devices and has instead been replaced by a separate new EU Regulation, IVDR (In-Vitro Diagnostic Regulation).
From 26 May 2022 new devices will have to meet the requirements of the IVDR in order to be placed in the European market. Products already certified by a Notified Body may be placed on the market until 25 May 2024 under some conditions and if the manufacturer fulfill the specific prerequisite requirements drawn in the IVDR.
Standards for electronic and mechanical medical devices
Regardless of whether it concerns electronics or mechanics, standards also form the basis for ensuring that components in medical technology systems and devices are compatible with each other. Standards also ensure that medical devices function reliably throughout their life cycle. Another advantage of standards is that their compliance facilitates the free movement of goods and simplifies the strictly regulated approval of medical technology systems and devices worldwide.
In medical technology, an internationally applicable standard for the electrotechnical sector is usually developed and published by the IEC and for the mechanical sector in general by ISO. However, it is not always easy to unambiguously classify a medical device as belonging to one or other of these areas. This is mainly due to the fact that modern medical devices are mostly of a systemic nature and that they are becoming increasingly complex. However, the system character is in fact a prerequisite for a medical device to be able to meet the ever-increasing requirements for medical diagnosis and therapy.
The emergence of product and process standards in medical technology
Germany was early with norms and standards and already in 1910 there were ideas for the standardization of individual medical devices. At that time, it was mainly technical products such as high-frequency surgical devices and the standards aimed to prevent physical hazards such as fire, electric shock or the like for both users and patients.
Medical devices were then developed for diagnosis, such as the Wilhelm Conrad X-ray machine or for treatments, such as infusion pumps, after which specific standards were created for many of these new medical devices.
The national standardizations were followed by international ones and in 1947 a new international standardization organization, ISO (International Organization for Standardization) was formed.
Technical design versus processes and methods
With regard to standards, a distinction is also made between two areas: 1) Standards for the technical design, especially for electrotechnical medical devices such as appliances and systems. 2) Standards that describe processes or methods, whereby this area includes not only risk-related standards but also quality management.
Due to the development in medical technology in recent years, the development of process standards has become important. These enable risk management of medical devices that are characterized by increased complexity due to technical innovations and whose commissioning is more risky.
The quality standard, on the other hand, refers to the process for the manufacture of medical devices, while risk management should minimize or exclude possible risks for patients, third parties and the environment.
Companies that manufacture a medical device should implement both processes to ensure that all regulatory requirements are met. It should also be noted that attempts were made in the past to achieve a strict distinction between product and process standards. However, it has been concluded that these two areas complement each other.
An overview of ten important standards in medical technology (without ranking)
1. ISO 13485:2016
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
2. ISO 9001:2015
Quality management system – Requirements
The standard ISO 9001 is a management system standard for business processes in a company or an organization. It is the world’s most widely used standard. There are just over 1.1 million certificates issued in 201 countries and new companies are certified every day.
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Benefits of working according to the standard
- engages the management
- improves business processes
- streamlines operations
- encourages internal communication and external communication
- increases customer satisfaction
- improves the possibility of winning procurements
- strengthens the brand.
- common structure for all ISO management system standards
- strengthened management responsibility
- new central areas, such as risk management and external monitoring
3. ISO 14971:2019
Medical devices – Application of a risk management system for medical devices
This document specifies the terminology, principles and a process for risk management of medical technology and in vitro diagnostic products. It also includes medical technology software. The process described in this document is intended to assist manufacturers of medical devices to identify the hazards associated with the equipment, to assess and evaluate the associated risks, to control these risks and to monitor the effectiveness of the controls.
The requirements of this document apply to all phases of the life cycle of a medical device. The process described in this document concerns risks related to biocompatibility, data and system security, electricity, moving parts, radiation and usability.
The process described in this document can also be applied to products that are not necessarily classified as medical devices in some countries and can also be used by others involved in the life cycle of medical devices.
This document does not apply to:
- decision on the use of a medical device in the context of a specific clinical procedure; or
- business risk management
The document requires manufacturers to establish objective criteria for risk acceptance but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE! Guidance for the application of this document can be found in ISO / TR 24971 .
4. ISO 20417:2021
Medical devices – Information to be supplied by the manufacturer
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
5. IEC 62366-1:2015
Medical devices – Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (Human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
6. ISO 15223-1:2016
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.
7. ISO 14155:2020
Clinical investigation of medical devices for human subjects – Good clinical practice
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
- protect the rights, safety and well-being of human subjects,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference ). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
8. ISO 10993-1:2018
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
— the patient’s body during intended use;
— the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
9. ISO 22870:2016
Point-of-care testing (POCT) — Requirements for quality and competence
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.
10. IEC 60601-1-12:2014/AMD 1:2020
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 used in the emergency medical services environment — Amendment 1
IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
In addition to these standards, there are of course many more that may be relevant. Batteries drive more and more devices and then IEC 62133 on rechargeable batteries or IEC 60086-4 on the safety requirements for lithium batteries may be relevant.
You can search for information and individual standards on the ISO website.
AMB is certified according to the quality standards ISO 9001, ISO 13485 and ISO 14001, where ISO 13485 refers to Manufacture of plastic products by injection molding, painting and assembly, surface treatment for EMC shielding and sterile packaging in clean rooms.