YY/T 0615.2-2007Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices (English PDF)

Foreword

YY/T 0615 "marked" sterile "medical device requirements," consists of the following components.

--- Part 1. eventually require sterilization of medical devices;

--- Part 2. aseptic processing medical equipment requirements.

YY/T 0615 is equivalent to using this part of EN556-2:2003 "marked" requires sterile "medical devices --- Part 2. Aseptic Processing requirements for medical devices. " This part of the National Standardization Technical Committee appliances medical infusion made.

This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.

This section is drafted. Shandong Medical Devices Product Quality Inspection Center.

Introduction

Labeled "sterile" medical devices is confirmed with a corresponding method for processing. However, sterile medical devices are not able to use a A suitable confirmed or controlled sterilization process (see YY/T 0615.1, GB 18278, GB 18279, GB 18280, ISO 14937), When a medical device is intended and can not be terminally sterilized sterile, aseptic processing is used in the manufacturing method thereof (see YY/T 0567 and ISO 14160). Aseptic processing requirements.

a) sterilization of the product before loading the container after sterilization; or

b) components sterilized products before further processing/assembling, packaging the final product in the container after sterilization.

Processing and packaging in the opportunity to make the project in a secondary pollution is minimal way, and so maintain a predetermined particle Limits and subject to a minimum of human intervention carried out under a controlled environment.

NOTE: YY 0466 prescribed identification symbol for aseptically processed medical devices.

1 Scope

YY/T 0615 provisions of this part of the declaration of "sterile" requirements of sterile processing of medical devices.

Note: When using a medical device only confirmed a sterilization process, it may be declared "sterile." YY/T 0567 provides for aseptic processing and often confirmation Regulatory control.

2 Normative references

The following documents contain provisions which, through YY/T 0615 reference in this text, constitute provisions of this part. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB 18278 Sterilization of health care products industry validation and routine control of moist heat sterilization (GB 18278-2000, idt ISO 11134:1994)

GB 18279 Medical Devices ethylene oxide sterilization validation and routine control (GB 18279-2000, idt ISO 11135:1994)

GB 18280 Sterilization of health care products requires validation and routine control of radiation sterilization (GB 18280-2000, idt ISO 11137:1995)

Characteristics of GB/T 19974-2005 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and often General requirements for regulatory control (GB/T 19974-2005, ISO 14937:2000, IDT)

YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485:2000, IDT)

ISO 14160. disposable medical equipment sterilization 1998 containing animal-derived materials --- liquid chemical sterilants and confirmation Conventional control

ISO 14937:2000 Sterilization of health care products sterilant --- --- features and development of medical equipment sterilization process validation and routine control

3 Terms and Definitions

The following terms and definitions apply YY/T 0615 of this section.