ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.
This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.
In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$256.00 NZD
|
|
| HardCopy |
$303.00 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Use of the terms “safety”, “safe”, “effective”, and “effectiveness”
4.1 Safety
4.2 Safe
4.3 Effective
4.4 Effectiveness
5 Principles for including aspects of safety in medical device standards
5.1 Scope of medical device standards that include aspects of safety
5.2 Objective of medical device standards that include aspects of safety
5.3 Types of standards
5.3.1 Product standards
5.3.2 Process standards
5.3.3 Installation and environmental standards
5.3.4 In-service standards
5.4 Taking a practical view of safety
5.5 Coordination of medical device standards
5.6 Implications of the regulatory or legal use of standards
6 The nature of risk
6.1 The elements of risk
6.2 Systematic or random nature of risks
6.2.1 Types of causes of risks
6.2.2 Risks arising from systematic causes
6.2.3 Risks arising from random causes
7 Risk-based process for developing a medical device standard that includes aspects of safety
7.1 General
7.2 Preparatory work
7.2.1 Identifying the need for a new or revised standard including aspects of safety
7.2.2 Establishing the risk management framework under which the standard will be developed
7.2.3 Risk acceptability criteria
7.3 Drafting
7.3.1 General
7.3.2 Iterative process of managing risk
7.3.3 Intended use and characteristics that can influence safety
7.3.4 Identification of hazards and hazardous situations
7.3.5 Risk estimation
7.3.6 Risk evaluation
7.3.7 Identification of risk controls
7.3.8 Verification of effectiveness
7.3.9 Assessment of residual risks
7.3.10 Impact of introduced risk control measures
7.3.11 All identified hazards and hazardous situations considered
7.4 Validation of the standard
7.5 Conclusion
8 Overview of the application of medical device standards including aspects of safety in a risk management framework
Annex A (informative) Product and process safety standards
Annex B (informative) Risk information
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2500:2020
Safe use of medical electrical equipment in health care -
AS/NZS 3200.1.2:2005
Medical electrical equipment - Part 1.2: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests -
AS/NZS 3200.1.8:2005
Medical electrical equipment - Part 1.8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems -
AS/NZS 3200.2.23:2001
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Use of the terms “safety”, “safe”, “effective”, and “effectiveness”
4.1 Safety
4.2 Safe
4.3 Effective
4.4 Effectiveness
5 Principles for including aspects of safety in medical device standards
5.1 Scope of medical device standards that include aspects of safety
5.2 Objective of medical device standards that include aspects of safety
5.3 Types of standards
5.3.1 Product standards
5.3.2 Process standards
5.3.3 Installation and environmental standards
5.3.4 In-service standards
5.4 Taking a practical view of safety
5.5 Coordination of medical device standards
5.6 Implications of the regulatory or legal use of standards
6 The nature of risk
6.1 The elements of risk
6.2 Systematic or random nature of risks
6.2.1 Types of causes of risks
6.2.2 Risks arising from systematic causes
6.2.3 Risks arising from random causes
7 Risk-based process for developing a medical device standard that includes aspects of safety
7.1 General
7.2 Preparatory work
7.2.1 Identifying the need for a new or revised standard including aspects of safety
7.2.2 Establishing the risk management framework under which the standard will be developed
7.2.3 Risk acceptability criteria
7.3 Drafting
7.3.1 General
7.3.2 Iterative process of managing risk
7.3.3 Intended use and characteristics that can influence safety
7.3.4 Identification of hazards and hazardous situations
7.3.5 Risk estimation
7.3.6 Risk evaluation
7.3.7 Identification of risk controls
7.3.8 Verification of effectiveness
7.3.9 Assessment of residual risks
7.3.10 Impact of introduced risk control measures
7.3.11 All identified hazards and hazardous situations considered
7.4 Validation of the standard
7.5 Conclusion
8 Overview of the application of medical device standards including aspects of safety in a risk management framework
Annex A (informative) Product and process safety standards
Annex B (informative) Risk information
Bibliography