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YY/T 0567.5-2011: Aseptic processing of health care products. Part 5: Sterilization in place
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| YY/T 0567.5-2011 | English | 314 |
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Aseptic processing of health care products. Part 5: Sterilization in place
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YY/T 0567.5-2011
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Basic data | Standard ID | YY/T 0567.5-2011 (YY/T0567.5-2011) | | Description (Translated English) | Aseptic processing of health care products. Part 5: Sterilization in place | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 16,161 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB 18281.1; GB 18281.2; GB 18281.3; GB 18282.1; GB 18282.3; GB 18282.4; GB/T 19003; GB/T 19972; GB/T 19974; YY/T 0567.1; YY/T 0567.4; ISO 17665-1 | | Adopted Standard | ISO 13408-5-2006, IDT | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the production of aseptically processed through sterile medical equipment, health products online product contact surface sterilization (SIP) General requirements and provide identification, validation, operation and control aspects of the guidelines. This standard applies to sterilizing agent is fed into the device's internal surfaces which contact with the product of the process. This section does not apply to the device is sent after the demolition of sterilization process. | YY/T 0567.5-2011: Aseptic processing of health care products. Part 5: Sterilization in place---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Aseptic processing of health care products.Part 5. Sterilization in place
ICS 11.080.01
C47
People's Republic of China pharmaceutical industry standards
Aseptic processing of health care products
Part 5. Sterilization online
Part 5. Sterilizationinplace
(ISO 13408-5.2006, IDT)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0567 "aseptic processing of health care products" is divided into the following sections.
--- Part 1. General requirements;
--- Part 2. Filter;
--- Part 3. lyophilization;
--- Part 4. Online cleaning technology;
--- Part 5. Online sterilization;
--- Part 6. Isolator systems.
This section YY/T Section 50567 of.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 13408-5.2006 "aseptically processed medical products - Part 5. Online sterilization", and
ISO 13408-5.2006 compared to the main editorial changes are as follows.
--- Other international standards cited in this section, if it has converted to our standards, this section will be referred to the International Standard into phase
Should the national standard number, and indicate the degree of consistency in the second chapter.
This part is proposed by the State Food and Drug Administration.
This part of the National Standardization Technical Committee and disinfection technology and equipment under the jurisdiction responsible for the interpretation.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, located in Hangzhou Tailin Biotechnology
Preparation Limited.
The main drafters of this section. Ke Jun, Wu Weirong, Yan Lin, Yeda Lin, Zhao Zhenbo.
Introduction
In the development of YY/T 0567.1 in the process, we found that some items, such as filtration, lyophilization and online sterilization techniques need to add a large number of letters
Interest rates, if the description of the content in the corresponding appendix excessive.
YY/T 0567 This section contains online during sterilization should pay attention to the requirements and guidelines. Objective YY/T 0567 This section is raw
Production of medical products online sterilization process validation and routine control standardization.
Under normal circumstances, the first for YY/T 0567.4 online described cleaning before sterilization online. Although the line cleaning and sterilization online
There are large differences in the method of the process, but their concept is similar to the processing line.
The most important question to consider establishing online sterilization technology is the design of the system should ensure that they are able to successfully produce equipment sterilization to
Expected sterility assurance level.
Aseptic processing of health care products
Part 5. Sterilization online
1 Scope
YY/T 0567 provisions of this section by aseptic processing of health care products to the production of sterile equipment product contact surfaces
Online sterilization (SIP) of the general requirements, and to provide authentication, validation, operation and control guidelines.
Note. SIP can be achieved through the use of steam or other gases or liquid sterilant. Appendix A gives the most common method --- Special steam sterilization online
guide.
This section applies to the sterilizing agent is fed to the interior surface of the device so that the process of contact with the product.
This section does not apply to the device is disassembled to the sterilization process.
This section does not replace or substitute for national regulatory requirements, particularly those belonging to the requirements of the jurisdiction within the country or region, such as production management practices
(GMPs) and/or the pharmacopoeia requirements.
This section does not require pathogen inactivation process developed spongiform encephalopathy, validation and routine control of specific requirements, such as scrapie, mad
Cow disease and Creutzfeldt-Jakob disease.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 18281 (all parts) Sterilization of health care products - Biological indicators (ISO 11138, IDT)
GB 18282 (all parts) Sterilization of health care products - Chemical indicators (ISO 11140, IDT)
GB/T 19003 software engineering GB/T 19001-2000 apply to computer software guide (GB/T 19003-2008,
ISO /IEC 90003.2004, IDT)
GB/T 19972 Sterilization of health care products - Biological indicators selection, use and test results to determine Guide (GB/T 19972-
2005, ISO 14161.2000, IDT)
Characteristics of GB/T 19974 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and routine control
General requirements (GB/T 19974-2005, ISO 14937.2000, IDT)
Aseptic processing Part 1 YY/T 0567.1 medical products. General requirements (YY/T 0567.1-2005, ISO 13408-1.
1998, IDT)
Aseptic processing YY/T 0567.4 health care products - Part 4. Online cleaning technology (YY/T 0567.4-2011,
ISO 13408-4.2005, IDT)
ISO 17665-1 Sterilization of health care products heat - Part 1. Medical device sterilization process development, validation and routine control of
Requirements (Sterilizationofhealthcareproducts-Moistheat-Part 1. Requirementsforthedevelopment,
validationandroutinecontrolofasterilizationprocessformedicaldevices)
3 Terms and Definitions
YY/T 0567.1 and define the following terms and definitions apply to this document.
3.1
Blind deadleg
Unable to make sterilizing agents in the design of full-reach areas.
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