YY/T 1600-2018Product family and processing category for steam sterilization of medical devices (English PDF)
医疗器械湿热灭菌的产品族和过程类别
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 19, 2018
Implementation date
January 1, 2019
Scope
YY/T 1600-2018 is the English-translated version of 医疗器械湿热灭菌的产品族和过程类别.
YY/T 1600-2018 is the Chinese pharmaceutical industry standard that sets out how a user groups medical devices into product families and processing categories according to their attributes, and chooses the moist heat sterilization cycle that suits each.
It is written for healthcare institutions, and can also be used by manufacturers of sterile devices and by those who provide reprocessing information under ISO 17664, so that a device is assigned to a validated cycle rather than to an arbitrary one. Issued on 19 January 2018, it has applied since 1 January 2019.
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Document preview — YY/T 1600-2018
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C 47
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Category
- 5 Product Family (PF)
- 6 Process category
- 7 Sterilization Process Parameters
- 8 Other notes
- Appendix A (informative) Process parameters
- Appendix B (Informative) Instrument Package Features - Example
- Appendix C (Informative) Process Category Setup Procedure
- Appendix D (Informative) Process Categories --- Example Reference
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.
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 document. 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
The most difficult to sterilize medical devices or kits in the product family or process category.
3.2 Process category
A collection of different products or product families that can be sterilized together.
3.3 Steam penetration resistance
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 Category
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 41 pages — is available in the English PDF.
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Related Standards
GB 18278.1-2015 — Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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