The medical device industry is amongst the most regulated industries in the world. Many regulations govern it, and many standards can be applied to ensure transparency in its processes.
In this regard, the top five internationally acclaimed and recognized standards that can be mentioned here are:
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- ISO 10993-1.
The latest edition of ISO 13485 is its third edition, which was published in 2016. The standard consists of 36 pages. It is a standard that puts forward the requirements for a Quality Management System (QMS). An organization can demonstrate its ability to provide medical devices and other related services. These organizations can be involved in one or more stages of the life cycle, including
These organizations can also be involved in
- Design and development of associated activities
- Provision of associated activities.
Suppliers or external parties that provide the product, including quality management system-related services to the organizations mentioned above, can also use ISO 13485.
The Processes of ISO 13485
All the processes required by ISO 13485:2016 can be applied to the organization, are the organization’s responsibility, and are accounted for by the organization’s QMS. This is done by monitoring, maintaining, and controlling the processes. Although the ISO 13485 processes can be applied to the organization, they are not performed.
The Requirements of ISO 13485
All the requirements of ISO 13485 apply to the organizations, regardless of their size and type, although exceptions will be considered in the cases where they are clearly stated.
ISO 14971:2019 is a standard developed for the manufacturers of medical devices on the established risk management principles. ISO 14971 helps manufacturers with risk management processes. The risks are not limited to injury to the patients only. Instead, their span also reaches the other persons. These risks can also be related to property damage or eth environmental damage.
The 2019 version of this standard has replaced the 2007 version of the standard. Some important changes that have been introduced in this version include:
- A clause of normative references for respecting the requirements of Clause 15 of ISO/IEC Directives, Part 2:2018
- The defied terms have been updated. Most of these terms are derived from ISO/IEC Guide 63:2019
- Definitions of the terms benefit, reasonably foreseeable misuse, and state of the art has been introduced
- The revised version of the standard gives more attention to the expected benefits of using the medical device
- The term “benefit-risk analysis” has also been put in correspondence with the terminology used in some regulations.
The requirements of ISO 14971 also provide the manufacturerswith a framework. This framework allows a systematic application of experience, insight, and judgment for managing risks associated with using the medical device.
IEC 60601-1-11:2015 provides general requirements for basic safety and essential performance of medical device equipment and medical electrical systems for their use in the home healthcare environment. The standard is applicable regardless of the fact that the medical electrical equipment or medical device system is intended to be used by a trained professional or by a lay operator.
Following are included in a home healthcare environment:
- The residential place in which the patient lives
- Other indoor and outdoor places where the patients are present. However, professional healthcare facilities with trained operators who are available during the presence of patients are excluded from the definition of a home healthcare environment.
The current edition of IEC 60601 is its second edition, and it canceled and replaced the first edition in IEC 60601-1-11 that was published in 2010. Some important changes and modifications that have been introduced in the current version of IEC 60601 are:
- Test method correction for relative humidity control at temperatures above 35 °C
- Redrafting the altered clauses instead of adding them to the general standard or other collateral standards
- Complying with the changes made in the general standard and other collateral standards.
IEC 62304 deals with the life cycle requirements for developing medical device software and software in medical devices. The EU and the USA harmonize this standard, and hence, it can be used in medical device markets of these regions.
The major implication of IEC 62304 is on using software, especially Software of Unknown Pedigree (SOUP). It presents a risk-based decision model that defines
- When the use of SOUP is acceptable
- Testing requirements for SOUP for supporting a rationale.
Software Development Process in Correspondence to IEC 62304
IEC 62304 presents the software development process as follows:
- Software development planning
- Software requirement analysis
- Software architectural design
- Software detailed design
- Software unit implementation and verification
- Software integration and integration testing
- Software system testing
- Software release.
Part 1 of ISO 1099 puts forward the requirements of biological evaluation of medical devices within a risk management process. The current edition of this standard in use is its fifth edition and was published in 2018.
ISO 10993-1 specifies the following important information:
- General principles that govern the biological evaluation of medical devices in correspondence to the risk management process
- General categorization and classification of the medical devices as per their nature and their duration of contact with the body
- Evaluation of existing data from all the sources
- Gaps identification in the available data based on risk analysis
- Identification of additional necessary data sets for analyzing the biological safety of the medical device.
The standard is also applicable for evaluating materials and medical devices expected to have either direct or indirect contact with the following:
- The patient’s body during the intended use
- The user’s body. This implies whether the medical device is intended to provide protection (e.g., surgical gloves, masks, and other items).
ISO 10993-1 also provides guidelines for assessing the biological hazards that may arise from:
- Changes occurring in the medical devices over time
- Breaking of a medical device or one of its components can expose the body tissues to new materials.
ISO 10993-1 also applies to the biological evaluation of all types of medical devices. These include active, non-active, implantable, and non-implantable medical devices. However, any hazards related to bacteria, molds, viruses, yeasts, TSE (Transmissible Spongiform Encephalopathy) agents, and other pathogens are excluded from the scope of this standard.
TSQ Asia has Expertise in These Standards
TSQ Asia has been working in t medical device industry for a very long time. Our experts are well-versed of the requirements of all of the standards applicable to the medical device industry, and they can greatly help a medical device organization in getting compliant to these standards. To learn more about our services in this regard, contact us through tsqasia.com.