1 Scope
This standard specifies the basic requirements for production and quality management of sterile medical devices and their parts and components.
The production of primary package materials for sterile medical devices shall also meet those specified in this standard.
2 Normative References
The following standards contain provisions which, through reference in this standard, constitute provisions of this standard. At time of publication, all the editions listed are valid. All standards are subject to revision. Parties to agreements based on this standard are encouraged to investigate the possibility of applying the latest editions of the standards indicated below.
GB/T 6583-1994 Quality Management and Quality Assurance - Vocabulary
GB/T 16292-1996 Test Method for Airborne Particles in Clean Room (Area) of the Pharmaceutical Industry
GB/T 16293-1996 Test Method for Airborne Microbe in Clean Room (Area) of the Pharmaceutical Industry
GB/T 16294-1996 Test Method for Settling Microbe in Clean Room (Area) of the Pharmaceutical Industry
YY/T 0313-1998 Package, Label, Transport and Storage for Medical Polymer Products
JGJ 71-1990 Code for Construction and Acceptance of Cleanroom
3 Definitions
For the purposes of this standard, the definitions in GB/T 6583 and YY/T 0313 and the following ones apply.
3.1 Lot
A certain quantity of products which are with the same property and quality and are produced under relatively stable condition.
3.2 Lot number
A set of numbers or letters and numbers used to identify "lot", which can trace and review the production history of this lot of products.
3.3 Production lot
A certain quantity of products which are with the same property and quality and are continuously produced under the same process condition in a period.
Note: to some continuously produced products, sometimes it’s difficult to determine the production lot. For the need of management, the products produced in one workday or shift are taken as a production lot.
3.4 Sterilization lot
A certain quantity of products which are sterilized under the same process condition in a sterilization cabinet and are also with the same sterility assurance level.
3.5 Sterilization
A validated process used to make products free of living microorganism in any form.
3.6 Sterile
The state that the medical device is free of living microorganism.
3.7 Primary package
Package directly contacting with the sterile medical device.
3.8 Sterile medical device
Any medical device identified as being “sterile”.
3.9 Clean room (area)
Room (area) where the content of dust particles and microorganism needs to be controlled, whose architectural structure, equipment and effect have the function of reducing the entry, generation and retention of pollution source in the room (area).
3.10 Cleanliness
The allowable statistical quantity of airborne particles which is larger than or equal to a certain particle size in unit volume of air in clean environment.
3.11 Air purification
Actions to make the air clean by removing the pollutant therein.
3.12 Personnel purification room
The auxiliary room in which the personnel are purified according to a certain procedure before entering into the clean room (area).
3.13 Material purification room
The auxiliary room in which the material is purified according to a certain procedure before being delivered into the clean room (area).
3.14 Material
Raw materials, auxiliary materials, packaging materials, purchased (outsourced) parts and accessories, etc.
Foreword I
1 Scope
2 Normative References
3 Definitions
4 Quality System
5 Production Environment, Facilities and Layout
6 Equipment and Tooling
7 Purchasing and Material Management
8 Documents
9 Quality Management
10 Production Process Management
11 Sanitation Management
12 Product Distribution and User Service
Appendix A (Normative) Air Cleanliness Class for Clean Room (Area) of Sterile Medical Devices
Appendix B (Normative) Guide for Setting Cleanliness Class of Production Environment for Sterile Medical Devices
Appendix C (Normative) Environment Requirements and Monitoring for Clean Room (area) of Sterile Medical Devices
Appendix D (Informative) General Procedure of Personnel Getting In and Out of Clean Production Area
Appendix E (Informative) Verification and Validation
Appendix F (Informative) Bibliography
