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YY/T 0640-2016 English PDF (YYT0640-2016)

YY/T 0640-2016 English PDF (YYT0640-2016)

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YY/T 0640-2016: Non-active surgical implants--General requirements

YY/T 0640-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
YY/T 0640-2016 / ISO 14630:3012
Replacing YY/T 0640-2008
Non-active surgical implants - General requirements
(ISO 14630:2012, IDT)
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 1, 2017
Issued by: State Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically and immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 8
4 Intended performance ... 10
5 Design attributes ... 10
6 Materials ... 12
7 Design evaluation ... 13
8 Manufacture ... 15
9 Sterilization ... 15
10 Packaging ... 16
11 Information supplied by the manufacturer ... 17
Bibliography ... 23
Foreword
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This Standard replaces YY/T 0640-2008 Non-active surgical implants -
General requirements. Compared with YY/T 0640-2008, the main differences in this Standard are as follows:
- modified the scope of the standard because this Standard does not
apply to the implants from active animal tissues;
- added the terms and definitions for “magnetic resonance environment”
(see 3.4) and “magnetic resonance imaging” (see 3.5);
- added some requirements for design attributes [see Clause 5 f], s), t), u), v)];
- made more detailed provisions on “pre-clinical evaluation” (see 7.2) and “post-market surveillance” (see 7.4);
- made more detailed provisions on “instructions for use” [see 11.3 a], t), u)];
- deleted “Annex A” of Edition 2008 and the content of “correspondence
of basic principles outlined in ISO/TR 14283”.
This Standard uses translation method to identically adopt ISO 14630:2012 Non-active surgical implants -- General requirements.
The Chinese documents which have consistency with the international
normative reference in this Standard are as follows:
- GB/T 7408-2005, Data elements and interchange formats - Information
interchange - Representation of dates and times (ISO 8601:2000, IDT)
- GB/T 16886.1-2011, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO
10993-1:2009, IDT)
- GB/T 16886.7-2001, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995, IDT)
- GB/T 19974-2005, Sterilization of health care products - General
requirement for characterization of a sterilization agent and the
development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000, IDT)
- YY/T 0297-1997, Clinical investigation of medical devices (ISO
14155:1996, IDT)
- YY 0970-2013, Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants (ISO 14160:1998, IDT)
- YY/T 0316-2008, Medical devices - Application of risk management to
medical devices (ISO 14971:2007, IDT)
- YY/T 0567.1-2013, Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, IDT)
- YY/T 0802-2010, Sterilization of medical devices - Information to be
provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004, IDT)
- YY/T 0771.1-2009, Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management (ISO 22442-1:2007, IDT)
- YY/T 0771.2-2009, Medical devices utilizing animal tissues and their
derivatives Part 2: Controls on sourcing, collection and handling (ISO
22442-2:2007, IDT)
- YY/T 0771.3-2009, Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management (ISO 22442-3:2007, IDT)
Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee on Surgical Implants and Orthopedic Instruments of Standardization
Administration of China (SAC/TC 110).
The drafting organizations of this Standard: Tianjin Medical Device Quality Supervision and Inspection Center, State Food and Drug Administration
Medical Device Technical Review Center.
Main drafters of this Standard: Ma Chunbao, Li Jia, Li Libin, Qi Baofen, Liu Bin, Min Yue, Sun Jiayi.
Version of standard substituted by this Standard is:
Introduction
This Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283 as they apply to non-active surgical implants. It also provides a method for demonstrating compliance with the relevant essential requirements as outlined in the general terms in Annex 1 of the European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as they apply to non-active surgical implants, hereafter referred to as implants. It might also help manufacturers comply with the requirements of other
regulatory bodies.
There are three levels of standards dealing with non-active surgical implants and related instrumentation. For the implants themselves, they are as follows, with level 1 being the highest.
- Level 1: General requirements for non-active surgical implants.
- Level 2: Particular requirements for families of non-active surgical
implants.
- Level 3: Specific requirements for types of non-active surgical implants. Level 1 standards, such as this Standard and Reference [4], contain
requirements that apply to all non-active surgical implants. They also
anticipate that there are additional requirements in the level 2 and level 3 standards.
Level 2 standards (see References [5], [6], [7], [8] and [9]) apply to a more restricted set or family of non-active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint
replacement.
Level 3 standards (see References [10], [11], [12] and [13]) apply to specific types of implants within a family of non-active surgical implants, such as hip joints or arterial stents.
To address all requirements for a specific implant, it is advisable that the standard of the lowest available level be consulted first.
NOTE: The requirements in this Standard correspond to international consensus. Individual or national standards or regulatory bodies can prescribe other requirements. Non-active surgical implants - General requirements
1 Scope
This Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This Standard is not applicable to dental implants, dental restorative materials, trans-endodontic and trans-radicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional tests are given or referred to in level 2 and level 3 standards. NOTE: This Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8601, Data elements and interchange formats - Information
interchange - Representation of dates and times
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a
sterilization process for medical devices
ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a
sterilization process for medical devices
ISO 11137-2, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 13408-1, Aseptic processing of health care products - Part 1: General requirements
ISO 14155, Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14160, Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14937, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices - Application of risk management to medical
devices
ISO 17664, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 17665-1, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a
sterilization process for medical devices
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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