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YY/T 1600-2018: Product family and processing category for steam sterilization of medical devices
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| YY/T 1600-2018 | English | 979 |
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Product family and processing category for steam sterilization of medical devices
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YY/T 1600-2018
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Basic data | Standard ID | YY/T 1600-2018 (YY/T1600-2018) | | Description (Translated English) | Product family and processing category for steam sterilization of medical devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 49,427 | | Date of Issue | 2018-01-19 | | Date of Implementation | 2019-01-01 | | Quoted Standard | GB 18278.1-2015 | | Adopted Standard | ISO/TS 17665-3-2013, MOD | | Regulation (derived from) | China Food and Drug Administration announced No. 8 of 2018 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard stipulates that the user classifies the product family and process category according to the attributes of the medical device, and selects the corresponding requirements for the hygrothermal sterilization program on the basis of this. | YY/T 1600-2018: Product family and processing category for steam sterilization of medical devices
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Product family and processing category for fluid sterilization of medical devices
ICS 11.080.01
C47
People's Republic of China Pharmaceutical Industry Standard
Medical Device Hygrothermal Sterilization Product Family and Process Category
(ISO /T S17665-3.2013, Sterilizationofhealthcareproducts-
Moistheat-Part 3. Guidanceonthedesignationofamedicaldevicetoa
Published on.2018-01-19
2019-01-01 Implementation
The State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Category 1
5 Product Family (PF) 4
6 Process category 7
7 Sterilization Process Parameters 7
8 Other notes 7
Appendix A (informative) Process parameters 9
Appendix B (Informative) Instrument Package Features - Example 11
Appendix C (Informative) Process Category Setup Procedure 25
Appendix D (Informative) Process Categories --- Example 26
Reference 41
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafted law to amend the use of ISO /T S17665-3.2013
A guide to the product family and process categories for medical devices.
The technical differences between this standard and ISO /T S17665-3.2013 and its causes are as follows.
--- With regard to normative references, this standard has made adjustments with technical differences to adapt to China's technical documents and adjust the situation.
The state of concentration is reflected in Chapter 2, “Normative References,” which is specifically. Replaced by GB 18278.1 that is equivalent to the international standard.
ISO 17665-1;
--- Added "4.1 Overview", in order to avoid confusion when quoting, avoid setting paragraphs between chapter titles and next levels;
--- Adjusted the order of the attributes "Material" and "Weight" in Table 1. The contents of table 1 in ISO /T S17665-3.2013 are in the wrong order.
This standard has made the following editorial changes.
--- Modified standard name.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Sanitary Technology and Equipment Standardization Technical Committee (SAC/TC200).
This standard was drafted. Guangdong Provincial Institute of Medical Device Quality Supervision, Maidi Jincheng Medical Devices Co., Ltd., Weihai Weigaohai
Sheng Medical Equipment Co., Ltd., Ballyman Medical Equipment (Shanghai) Co., Ltd.
The main drafters of this standard. Liang Zexin, Hu Changming, Ke Jun, Lu Liansheng, Jiang Wei, Xu Weixiong, Cao Jianhong, and Jin Youshan.
Medical Device Hygrothermal Sterilization Product Family and Process Category
1 Scope
This standard stipulates that the user classifies the product family and process category according to the attributes of the medical device and selects the corresponding wet
Heat sterilization procedure requirements.
Note. This standard may also be used by providers of sterile medical device manufacturers and/or device reprocessing information (see ISO 17664) in addition to medical institutions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 18278.1-2015 Sterilization of heat and heat for health care products. Part 1. Development, validation and routines of the sterilization process for medical devices
Control Requirements (ISO 17665-1.2006, IDT)
3 Terms and Definitions
The terms defined in GB 18278.1-2015 and the following terms and definitions apply to this document.
3.1
The main product masterproduct
The most difficult to sterilize medical devices or kits in the product family or process category.
3.2
Process category processingcategory
A collection of different products or product families that can be sterilized together.
3.3
Steam penetration resistance steampenetrationresistance
The challenge of the hygrothermal sterilization process for medical devices (including sterile barrier systems/packaging systems) that delays all parts of the medical device
Obtain sterilization process parameters.
3.4
User user
Ensure that the product is sterilized and responsible for the intended use of the person or group.
Category 4
4.1 Overview
Each medical device, whether new or improved, should be classified using the attributes listed in Table 1. Specific features of medical devices
Sex is identified by 4.3.
NOTE 1 The relevant requirements for reprocessing information on reusable medical devices provided by manufacturers are given in ISO 17664.
If a sterile barrier system/packaging system contains several medical devices (for example, equipment packages), each
The challenge of the sterilization process of a medical device is assessed and the assessment needs to consider the relevance to other medical devices. The product family to which the device package belongs,
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