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PD ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices, 2019
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Use of the terms “safety”, “safe”, “effective”, and “effectiveness” [Go to Page]
- 5 Principles for including aspects of safety in medical device standards [Go to Page]
- 6 The nature of risk [Go to Page]
- 7 Risk-based process for developing a medical device standard that includes aspects of safety [Go to Page]
- 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 [Go to Page]