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SN/T 0323.1-2007 English PDF

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Q: Should I purchase the latest version SN/T 0323.1-2007?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version SN/T 0323.1-2007 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$289.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
SN/T 0323.1-2007: Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use
Status: Valid

SN/T 0323.1: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
SN/T 0323.1-2007	289	Add to Cart	3 days	Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use	Valid
SN/T 0323-1994	239	Add to Cart	2 days	Rules for the inspection of sterile hypodermicsyringes for single use for export	Obsolete

Similar standards

GB/T 6499 GB/T 6102.2 GB/T 11763 SN/T 4492 SN/T 3577 SN/T 0311.2

Basic data

Standard ID: SN/T 0323.1-2007 (SN/T0323.1-2007)
Description (Translated English): Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use
Sector / Industry: Commodity Inspection Standard (Recommended)
Classification of Chinese Standard: B32
Classification of International Standard: 59.060.10
Word Count Estimation: 9,930
Date of Issue: 2007-12-24
Date of Implementation: 2008-07-01
Older Standard (superseded by this standard): SN/T 0967-2000
Quoted Standard: GB/T 2828.1; GB 8368-2005; GB 8369-2005; GB/T 14233.1; GB/T 14233.2; GB 18671-2002; SN/T 0002; YY 0466
Regulation (derived from): ?Industry Standard Filing Announcement 2008 No.2 (Total No.98)
Issuing agency(ies): General Administration of Customs
Summary: This standard specifies the import and export of disposable infusion (blood) The sampling, testing and conformity determination. This standard applies to single use, gravity infusion-type disposable infusion sets and disposable blood transfusion.

SN/T 0323.1-2007: Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use

---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.
Rules for the inspection of medical equipment for import and export Part 1. Infusion and transfusion sets for single use Exit inspection and quarantine industry standard book People's Republic of China Instead of the SN/T 0967-2000 Inspection of import and export of medical devices Part 1. The one-time infusion (blood) control Posted 2007-12-24 2008-07-01 implementation People's Republic of China The State Administration of Quality Supervision, Inspection and Quarantine released

Foreword

SN/T 0323 "Importers of medical equipment for the inspection," is divided into three parts. --- Part 1. one-time infusion (blood) control; --- Part 2. a one-time use of sterile syringes; --- Part 3. human blood and blood components bag plastic containers conventional blood bag. This section SN/T Section 10323 of. The partial replacement of SN/T 0967-2000 "export disposable infusion, blood transfusion test procedures." This section compared with the SN/T 0967-2000 The main changes are as follows. --- Increased imports of disposable infusion (blood) section; --- Technical requirements and test methods used in ISO 8536-4.2004, ISO 1135-4.2004, ISO 594-1. 1986 and other international standard; --- Term corresponds with international standards; --- Modify the scope of regulations; --- Increased the intake device, protective cover and injection member requirements; --- Provide increased process control inspection lot sterilization validation reports and batch quality records; --- Increased imports conformity assessment models; --- Increase unpacking inspection test mode. This section in Appendix A and Appendix B is an informative annex. This section proposed and managed by the National Certification and Accreditation Administration Committee. This section was drafted by. People's Republic of China Exit Inspection and Quarantine of Jilin, Jilin Medical Device Testing. The main drafters of this section. Song Yongli, Zhang Jingping, Caizhao Hong, Wu Ping, Hou Wan bell. This part of the standard replaces the previous editions are. --- SN/T 0967-2000. Inspection of import and export of medical devices Part 1. The one-time infusion (blood) control

1 Scope

SN/T 0323 provisions of this part of the import and export one-time infusion (blood) the sampling, testing and conformity determination. This section applies to single-use, disposable type gravity infusion infusion (hereinafter referred to as the "infusion") and one-time use of transfusion Hematocrit (hereinafter referred to as "blood transfusion").

2 Normative references

The following documents contain provisions which, through reference SN/T 0323 this section, 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/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan (ISO 2859-1.1999, IDT) GB 8368-2005 disposable infusion gravity infusion of formula (ISO 8536-4.2004, MOD) GB 8369-2005 disposable blood transfusion (ISO 1135-4.2004, MOD) GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB 18671-2002 disposable intravenous infusion needle The basic provisions of SN/T 0002 Electromechanical Import and Export Commodity Inspection procedures prepared Symbol YY0466 medical equipment used with medical device labels, labeling and information provided

3 Terms and Definitions

GB/T 2828.1, SN/T 0002 and established the following terms and definitions apply to SN/T 0323 of this section. 3.1 According to a predetermined cycle based on the mandatory requirements of national technical specifications type testing, according to the scene to examine the provisions of the product or batch Pumping batch sampling, determination and implementation of qualified supervision activities of the enterprise quality management system. 3.2 Mandatory requirements by national technical specifications, by checking the technical documentation and the necessary by-batch or batch sampling pump, for goods Compliance Judgment and evaluation activities. 3.3 When imported goods at the port of entry in accordance with relevant state regulations for goods related files, documents, technical data and goods mainly conducted Inspection activities. 3.4 For the implementation of sampling and collection of the same specifications, models, produced under the same conditions of production per unit of product, referred to as batch. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of SN/T 0323.1-2007_English be delivered?

Answer: Upon your order, we will start to translate SN/T 0323.1-2007_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 SN/T 0323.1-2007_English with my colleagues?

Answer: Yes. The purchased PDF of SN/T 0323.1-2007_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.

Question 5: Should I purchase the latest version SN/T 0323.1-2007?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version SN/T 0323.1-2007 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.