YY/T 0771.1-2020Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (English PDF)

1 Scope

This part of YY/T 0771 specifies the identification and use of animal-derived materials (inactive or rendered inactive) for medical devices

Equipment-related hazards (sources) and hazardous situations, the estimation, evaluation and control of the resulting risks, and procedures for monitoring the effectiveness of these controls (Combined with YY/T 0316-2016).

This section applies to medical devices manufactured from animal-derived materials (inactive or rendered inactive), excluding in vitro diagnostic medicine

Therapeutic equipment.

This section does not apply to medical devices that use human tissue.

This section does not specify a quality management system for the control of the entire production stage of medical devices.

In addition, taking into account the residual risk defined in YY/T 0316-2016 and weighing the expected medical comparison with other alternatives

Treatment benefit, this section gives the judgment process of the acceptability of residual risk, as well as medical devices manufactured using animal tissue or its derivatives

Requirements and guidelines for risk management of hazards (sources) .These hazards (sources) include.

a) Bacterial, mold or yeast contamination;

b) virus contamination;

c) Contaminated Spongiform Spongiform Encephalopathy (TSE) factors;

d) Unwanted pyrogenic, immunological or toxicological reactions caused by the material.

Similar principles apply to parasites or other unclassified pathogens.

Note 1. The operation of a comprehensive quality management system during the production process is not a requirement of this part. See the quality management system for the control of all stages of medical device production or reprocessing

For the standard, see YY/T 0287.

Note 2. Refer to Appendix A for application guidance in this section.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article

Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-

2011, ISO 10993-1..2009, IDT)

YY/T 0316-2016 Application of medical device risk management to medical devices (ISO 14971..2007, IDT)

YY/T 0771.2-2020 Medical devices of animal origin Part 2. Control of source, collection and disposal (ISO 22442-2..2015,

MOD)

YY/T 0771.3 Medical Devices of Animal Origin Part 3. Virus and Transmissible Spongiform Encephalopathy (TSE) Factor Elimination and Inactivation

Confirmation (YY/T 0771.3-2009, ISO 22442-3..2007, IDT)

3 Terms and definitions

The terms and definitions defined in YY/T 0316-2016 and the following apply to this document.