GB 18282.4-2009 PDF English
US$490.00 · In stock · Download in 9 secondsGB 18282.4-2009: Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration 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 18282.4-2009 | English | 490 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB 18282.4-2009
GB 18282.4-2009: Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
---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/GB18282.4-2009
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18282.4-2009 / ISO 11140-4.2007
Sterilization of Health Care Products – Chemical Indicators
– Part 4.Class 2 Indicators as an Alternative to the Bowie
and Dick-Type Test for Detection of Steam Penetration
(ISO 11140-4.2007, IDT)
Issued on. NOVEMBER 15, 2009
Implemented on. DECEMBER 01, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 7
4 General Requirements... 8
5 Indicator System Format... 10
6 Performance Requirements... 10
7 Packaging and Labelling... 12
8 Quality Assurance... 14
Annex A (Normative) Determination of Indicator Strength during and after Steam
Sterilization... 15
Annex B (Normative) Standard Test Cycles... 17
Annex C (Normative) Estimation of Visual Difference Between Color of the Substrate
and of the Changed or Unchanged Indicator System by Determination of Relative
Reflectance Density... 23
Annex D (Normative) Determination of Uniform Color Change on Exposure to
Saturated Steam... 27
Annex E (Normative) Determination of Equivalence of the Alternative Indicator to the
Bowie and Dick Test... 28
Annex F (Normative) Determination of Reproducibility of Fail Conditions Created in
a Standard Test Pack by Air Injection, Air Leak and Retained Air Systems... 30
Annex G (Normative) Determination of Indicator Color Change on Exposure to Dry
Heat... 34
Annex H (Normative) Determination of Shelf Life of Product... 35
Annex I (Normative) Accelerated Ageing of Test Samples... 36
Annex J (Normative) Steam exposure Apparatus and Steam for Test Purposes... 37
Annex K (Normative) Standard Test Pack... 40
Annex L (Normative) Air Injection System... 41
Bibliography... 43
Foreword
All the technical contents in this Part are mandatory.
GB 18282 Sterilization of Health Care Products – Chemical Indicators consists of the following
parts.
--- Part 1.General;
--- Part 3.Class 2 Indicator Systems for Use in the Bowie and Dick-Type Steam Penetration
Test;
--- Part 4.Class 2 Indicators as an Alternative to the Bowie and Dick-Type Test for Detection
of Steam Penetration;
--- Part 5.Class 2 Indicators for Bowie and Dick-Type Air Removal Tests.
This Part is Part 4 of GB 18282.
This Part equivalently adopts ISO 11140-4.2007 Sterilization of Health Care Products –
Chemical Indicators – Part 3.Class 2 Indicators as an Alternative to the Bowie and Dick-Type
Test for Detection of Steam Penetration.
Compared with ISO 11140-4.2007, the major differences with this Part are as follows.
--- Make the editorial modifications as per the requirements in GB/T 1.1;
--- Delete the Foreword of the international standard;
--- For other international standards cited in this Part, if they have been converted into
Chinese standards, this Part will replace the referenced international standard number
with the corresponding national standard number, and indicate the adoption relationship.
The Annexes A ~ L of this Part are normative.
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).
Drafting organizations of this Part. Guangzhou Medical Device Quality Supervision and
Inspection Center of State Food and Drug Administration; and Shinva Medical Instrument Co.,
Ltd.; and 3M China Ltd.
Chief drafters of this Part. Hu Xianghua, Huang Hongxin, Yuan Qin, Lu Wenjuan, He Xiaofan,
Wang Jiuru, and Huang Jingxiong.
1 Scope
This Part of GB 18282 specifies the performance for a Class 2 indicator to be used as an
alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods
(instruments, etc., and porous loads).
2 Normative References
The provisions in following documents become the provisions of this Part through reference in
this Part of GB 18282.For dated references, the subsequent amendments (excluding
corrigendum) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced document
applies.
GB/T 11501 Photography - Density Measurement - Part 3.Spectral Conditions (GB/T
11501-2008, ISO 5-3.1995, IDT)
3 Terms and Definitions
For the purposes of this Part of GB 18282, the terms and definitions given in ISO 11140-1 and
the following apply.
Indicator in which the user combines the indicator system with the test load prior to use.
4 General Requirements
Compliance with the requirements of this Part of GB 18282 shall be determined by
establishing conformity with the performance requirements of Clause 6.
5 Indicator System Format
When the indicator system is provided by the manufacturer already incorporated into the
test load, the material of either the indicator or the indicator system, as appropriate, shall permit
writing to be made after processing.
6 Performance Requirements
Indicators intended for use only with specific air removal cycles shall be tested with those
specific cycles only (see 5.7 of ISO 11140-1.2005).
7 Packaging and Labelling
When a manufacturer provides similar products which are intended only for specific
sterilization cycles, the product shall include identification sufficient to enable the user to
determine, from the instructions for use, any restrictions on the use of the product.
8 Quality Assurance
The quality system shall ensure that the performance requirements given in Clause 6 are
maintained.
Suitable records shall be maintained to ensure that, if necessary, faulty batches can be
recalled from use.
Annex A
(Normative)
Determination of Indicator Strength during and after Steam Sterilization
Steam exposure apparatus, as specified in Annex J.
Annex B
(Normative)
Standard Test Cycles
The standard test cycle for sub-atmospheric air removal shall consist of the following steps.
Annex C
(Normative)
Estimation of Visual Difference Between Color of the Substrate and of the
Changed or Unchanged Indicator System by Determination of Relative
Reflectance Density
......
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 18282.4-2009 be delivered?Answer: The full copy PDF of English version of GB 18282.4-2009 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 18282.4-2009_English with my colleagues?Answer: Yes. The purchased PDF of GB 18282.4-2009_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 18282.4-2009 -- 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 18282.4-2009?A step-by-step guide to download PDF of GB 18282.4-2009_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 18282.4-2009".
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
|