|
US$289.00 ยท 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: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| SN/T 0323.1-2007 | English | 289 |
Add to Cart
|
3 days [Need to translate]
|
Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use
| Valid |
SN/T 0323.1-2007
|
| SN/T 0323-1994 | English | 239 |
Add to Cart
|
2 days [Need to translate]
|
Rules for the inspection of sterile hypodermicsyringes for single use for export
| Obsolete |
SN/T 0323-1994
|
PDF similar to SN/T 0323.1-2007
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Count Estimation | 9,930 | | Date of Issue | 2007-12-24 | | Date of Implementation | 2008-07-01 | | Older Standard (superseded by this standard) | SN/T 0967-2000 | | Quoted Standard | GB/T 2828.1; GB 8368-2005; GB 8369-2005; GB/T 14233.1; GB/T 14233.2; GB 18671-2002; SN/T 0002; YY 0466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.
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+ countriesQuestion 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 [email protected]. 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.
|