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YY/T 0615.2-2007 English PDF

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US$154.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0615.2-2007: Requirements for medical devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0615.2-2007	154	Add to Cart	3 days	Requirements for medical devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices	Valid

Similar standards

YY/T 0802.1 YY/T 1268 YY 0451 YY/T 0802.2

Basic data

Standard ID: YY/T 0615.2-2007 (YY/T0615.2-2007)
Description (Translated English): Requirements for medical devices to be designated ��STERILE��. Part 2: Requirements for aseptically processed medical devices
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 8,892
Date of Issue: 2007-07-02
Date of Implementation: 2008-03-01
Quoted Standard: GB 18278; GB 18279; GB 18280; GB/T 19974-2005; YY/T 0287; ISO 14160-1998; ISO 14937-2000
Adopted Standard: EN 556-2-2003, IDT
Regulation (derived from): Chinese industry standard filing Notice 2007 No. 9 (No. 93 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the labeled " sterile " of aseptically processed medical devices requirements.

YY/T 0615.2-2007: Requirements for medical devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices

---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.
Requirements for medical devices to be designated "STERILE" .Part 2. Requirements for aseptically processed medical devices ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Labeling requirements "sterile" medical devices Part 2. Requirements aseptically processed medical devices (EN556-2.2003, IDT) Posted 2007-07-02 2008-03-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0615 "marked" sterile "medical device requirements," consists of the following components. --- Part 1. eventually require sterilization of medical devices; --- Part 2. aseptic processing medical equipment requirements. YY/T 0615 is equivalent to using this part of EN556-2.2003 "marked" requires sterile "medical devices --- Part 2. Aseptic Processing requirements for medical devices. " This part of the National Standardization Technical Committee appliances medical infusion made. This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Wu Ping by Shaohua.

Introduction

Labeled "sterile" medical devices is confirmed with a corresponding method for processing. However, sterile medical devices are not able to use a A suitable confirmed or controlled sterilization process (see YY/T 0615.1, GB 18278, GB 18279, GB 18280, ISO 14937), When a medical device is intended and can not be terminally sterilized sterile, aseptic processing is used in the manufacturing method thereof (see YY/T 0567 and ISO 14160). Aseptic processing requirements. a) sterilization of the product before loading the container after sterilization; or b) components sterilized products before further processing/assembling, packaging the final product in the container after sterilization. Processing and packaging in the opportunity to make the project in a secondary pollution is minimal way, and so maintain a predetermined particle Limits and subject to a minimum of human intervention carried out under a controlled environment. NOTE. YY 0466 prescribed identification symbol for aseptically processed medical devices. Labeling requirements "sterile" medical devices Part 2. Requirements aseptically processed medical devices

1 Scope

YY/T 0615 provisions of this part of the declaration of "sterile" requirements of sterile processing of medical devices. Note. When using a medical device only confirmed a sterilization process, it may be declared "sterile." YY/T 0567 provides for aseptic processing and often confirmation Regulatory control.

2 Normative references

The following documents contain provisions which, through YY/T 0615 reference in this text, constitute provisions of this part. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB 18278 Sterilization of health care products industry validation and routine control of moist heat sterilization (GB 18278-2000, idt ISO 11134.1994) GB 18279 Medical Devices ethylene oxide sterilization validation and routine control (GB 18279-2000, idt ISO 11135.1994) GB 18280 Sterilization of health care products requires validation and routine control of radiation sterilization (GB 18280-2000, idt ISO 11137.1995) Characteristics of GB/T 19974-2005 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and often General requirements for regulatory control (GB/T 19974-2005, ISO 14937.2000, IDT) YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485.2000, IDT) ISO 14160. disposable medical equipment sterilization 1998 containing animal-derived materials --- liquid chemical sterilants and confirmation Conventional control ISO 14937.2000 Sterilization of health care products sterilant --- --- features and development of medical equipment sterilization process validation and routine control

3 Terms and Definitions

The following terms and definitions apply YY/T 0615 of this section. 3.1 In a controlled environment (air supply, materials, equipment and personnel have been regulated so that microbial contamination and particulate pollution control to be Acceptance level), or a sterile container and instrument components disposal and filling. 3.2 Product and/or the total number of viable microorganisms on the packaging. 3.3 Microbial growth medium to assess the effectiveness of simulation aseptic processing used to control. Note. the culture medium, also known as filling process simulation test, filling simulation, simulation of filling operation, test broth, broth filling. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0615.2-2007_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0615.2-2007_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0615.2-2007_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0615.2-2007_English will be deemed to be sold to your employer/organization who actually pays 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+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.