YY/T 1402-2016Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization (English PDF)

1 Scope

This standard specifies that the process challenge device is more difficult to achieve sterilization conditions than the simulated medical device in terms of degassing and vapor permeation

Test Methods.

The process challenge device is suitable for GB 8599-2008 requirements of large-scale sterilizer and YY 0646-2008 requirements of the small off

Bacteria (including B-type cycle). This procedure confirms that a qualified process challenge device is only valid for simulated medical devices.

Note 1. Similar medical devices may have completely different internal structures. These differences may affect the degassing and steam penetration, which in turn affects the process challenge

The validity of the set.

Note 2. The proven process challenge device is used only for the verification process of the degassing and vapor permeation of the simulated medical device.

NOTE 3 The process challenge devices specified in this standard may also be used for the development of sterilization processes.

NOTE 4 The process challenge devices specified in this standard do not necessarily apply to other requirements of the relevant medical device (see 8.2).

This standard does not specify the design and materials of the process challenge device.

2 normative reference documents

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

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB 8599-2008 Large steam sterilizer technical requirements Automatic control type (GB 8599-2008, EN285..2006, NEQ)

GB 18281.1 Sterilization products for health care products - Part 1. General principles (GB 18281.1-2000, ISO 11138-

1..1994, IDT)

GB 18281.3 Sterilization products for health care products - Part 3. Biological indicators for damp heat sterilization (GB 18281.3-

2000, ISO 11138-3..1995, IDT)

GB 18282.1 Sterilization products for medical care products Part 1 General Provisions (GB 18282.1-2000, ISO 11140-1.

1995, IDT)

Sterilization counters for medical care products - Part 4. for the identification of alternative BD - type vapor permeation tests GB 18282.4-2009

Two types of indicators (GB 18282.4-2009, ISO 11140-4..2007, IDT)

GB/T 19001-2008 Quality management system requirements

GB/T 19022-2003 measurement management system measurement process and measurement equipment requirements (GB/T 19022-2003,

ISO 10012..2003, IDT)

GB/T 19633-2005 Packaging of final sterilized medical devices (GB/T 19633-2005, ISO 11607..2003, IDT)

GB/T.19972-2005 Guideline for the selection, use and test of sterilization biological indicators for health care products (GB/T.19972-2005, ISO 14161..2000, IDT)

GB/T.19973.1-2015 Sterilization methods for medical devices - Part 1. Determination of the total number of microorganisms on a product (GB/T.19973.1-2005, ISO 11737-1..1995, IDT)

GB/T.19973.2-2005 Microbiological methods for sterilization of medical devices - Part 2. Sterility test for confirmation of sterilization (GB/T.19973.2-2005, ISO 11737-2..1998, IDT)

GB/T 27025-2008 General requirements for testing and calibration laboratory capabilities (GB/T 207025-2008, ISO /IEC 17025.