GB/T 18279.2-2015 PDF English
US$500.00 · In stock · Download in 9 secondsGB/T 18279.2-2015: Sterilization of health care products -- Part 2: Guidance on the application of GB 18279.1 Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 18279.2-2015 | English | 500 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Sterilization of health care products -- Part 2: Guidance on the application of GB 18279.1
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB/T 18279.2-2015
GB/T 18279.2-2015: Sterilization of health care products -- Part 2: Guidance on the application of GB 18279.1
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT18279.2-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB/T 18279.2-2015 / ISO/TS 11135-2.2008
Partially replacing GB 18279-2000
Sterilization of health care products - Part 2.Guidance on
the application of GB 18279.1
(ISO/TS 11135-2.2008, Sterilization of health care products - Part 2.Guidance on the
application of ISO 11135-1, IDT)
Issued on. DECEMBER 10, 2015
Implemented on. JULY 01, 2017
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 7
4 Quality management systems... 8
5 Sterilizing agent characterization... 9
6 Process and equipment characterization... 9
7 Product definition... 11
8 Process definition... 17
9 Validation... 21
10 Routine monitoring and control... 31
11 Product release from sterilization... 34
12 Maintaining process effectiveness... 35
Annex A (informative) Guidance on GB 18279.1-2015 Annex A Determination of
process lethality - Biological indicator/bioburden approach... 40
Annex B (informative) Guidance on GB 18279.1-2015 Annex B Conservative
determination of lethal rate of the sterilization process - Overkill approach... 51
Bibliography... 54
Foreword
GB 18279 "Sterilization of health care products" consists of the following parts.
- Part 1.Requirements for development, validation and routine control of a
sterilization process for medical devices;
- Part 2.Guidance on the application of GB 18279.1.
This Part is Part 2 of GB 18279.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part together with GB 18279.1 replaces GB 18279-2000 "Medical devices.
Validation and routine control of ethylene oxide sterilization".
This Part identically uses ISO/TS 11135-2.2008 "Sterilization of health care products -
Part 2.Guidance on the application of ISO 11135-1".
The Chinese documents which have consistency with the international normative
reference in this Part are as follows.
- GB 18282.1-2015, Sterilization of health care products - Chemical indicator - Part
1.General requirements (ISO 11140-1.2005, IDT);
- GB/T 19973.1-2015, Sterilization of medical devices - Microbiological methods -
Part 1.Determination of a population of microorganisms on products (ISO 11737-
1.2006, IDT);
- YY/T 0287-2003, Medical devices. Quality management systems. Requirements
for regulatory purposes (ISO 13485.2003, 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).
This Part made the following editorial changes.
- Some editorial modifications have been made in accordance with the requirements
of GB/T 1.1;
- The foreword of ISO/TS 11135-2.2008 is deleted;
- Some international standards appearing in the introduction and references are
replaced by corresponding Chinese standards.
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Disinfection Technology and Equipment of Standardization Administration of China
(SAC/TC 200).
The drafting organizations of this Part. Hangzhou Unique Disinfection Equipment Co.,
Ltd., Guangzhou Medical Device Quality Supervision and Inspection Center of the
State Food and Drug Administration, Terumo Medical Products (Hangzhou) Co., Ltd.,
Guangzhou Yangpu Medical Technology Co., Ltd., Shijie Medical Technology
(Shanghai) Co., Ltd.
Main drafters of this Part. Chen Zhiling, Zhou Qingqing, Hu Changming, Lin Yuqing,
Weng Hui, Gong Yaoren, Gao Li, Min Jie, Xu Haiying.
Version of standard substituted by this Part is.
- GB 18279-2000.
1 Scope
This Part of GB 18279 provides guidance for the requirements in GB 18279.1-2015.It
does not repeat the requirements and is not intended to be used in isolation.
The exclusions in GB 18279.1 apply also to this Part.
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.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
person with knowledge of the sterilization technology being utilized and its effects upon
materials and microorganisms
4 Quality management systems
It is recommended that the identity of the person who assembled the pack also be
included on the identifier, to allow for further investigation if a problem should arise.
Lot identification information enables personnel to retrieve items in the event of a recall
and to trace problems to their source.
5 Sterilizing agent characterization
EO is a highly penetrative gas that will permeate most packaging materials and
polymeric materials. Widely recognized compositions include 100% EO and blends
with carbon dioxide or nitrogen. The storage conditions for EO should be in accordance
with the EO manufacturer’s recommendations and all applicable regulations.
6 Process and equipment characterization
In health care facilities, process and equipment characterization are generally the
responsibility of the sterilizer manufacturer.
The equipment specification should be reviewed to ensure that regulatory and safety
requirements are met, technical specifications are appropriate, and services and
infrastructure necessary to operate the equipment are available.
7 Product definition
The demonstration that the specified sterilization process does not affect the
correct functioning of the product may be accomplished by performing functionality
tests, or other appropriate tests, on the medical device and packaging following
sterilization. These tests may range from a simple visual inspection to a battery of
specialized tests.
8 Process definition
If the medical device or packaging manufacturer supplies instructions for reprocessing
that are not specific enough or not appropriate (e.g., an EO process with 100 % EO,
where the health care facility uses a blend), the facility should either perform a
validation or assess the appropriateness of its own reprocessing method, based on
materials effect data and reprocessing instructions for other devices.
9 Validation
PQ consists of rigorous microbiological and physical testing, beyond routine
monitoring, to demonstrate the efficacy and reproducibility of the sterilization process.
PQ is normally not started until after completion and approval of the IQ and OQ testing.
Acceptance criteria should include conformance with the specifications for the
sterilization process parameters and microbiological challenge.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of GB/T 18279.2-2015 be delivered?Answer: The full copy PDF of English version of GB/T 18279.2-2015 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of GB/T 18279.2-2015_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 18279.2-2015_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB/T 18279.2-2015 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. How to buy and download a true PDF of English version of GB/T 18279.2-2015?A step-by-step guide to download PDF of GB/T 18279.2-2015_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "GB/T 18279.2-2015".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|