Valid

YY 1048-2016Cardiopulmonary bypass systems - Extracorporeal blood circuit (English PDF)

心肺转流系统体外循环管道

Preview PDF

This is a limited preview

Buy now to download the full PDF (9 pages)

Need quotation for your management?

Get a formal quotation for YY 1048-2016 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 23, 2016

Implementation date

January 1, 2018

Scope

YY 1048-2016 is the English-translated version of 心肺转流系统体外循环管道.

YY 1048-2016 is the Chinese standard "Cardiopulmonary bypass systems - Extracorporeal blood circuit".

Its scope clause reads: This standard specifies the cardiopulmonary bypass system of extracorporeal circulation pipeline (hereinafter referred to as the pipeline) classification and naming, requirements, test methods, signs, packages Equipment, transportation, storage.

This standard applies to cardiopulmonary bypass system used in the extracorporeal circulation of the pipeline and its associated with the auxiliary pipeline, the product in the cardiovascular Surgery for extracorporeal circulation as a blood channel and channel connection used for one-time use. Its clauses include normative reference documents.

Found what you need?

Document preview — YY 1048-2016

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45
Replacing: YY 1048-2007

Issued by: National Medical Products Administration

4 Requirements1
4.1 Appearance1
4.2 Physical properties2
4.3 Biological properties2
4.4 Chemical properties2
4.5 valid period3
5 Test methods3
5.1 Appearance3
5.2 Physical properties3
5.3 Biological properties3
5.4 Chemical performance test3
5.5 Validity test4
6 mark, packaging, transportation, storage4

1 Scope

This standard specifies the cardiopulmonary bypass system of extracorporeal circulation pipeline (hereinafter referred to as the pipeline) classification and naming, requirements, test methods, signs, packages

Equipment, transportation, storage.

This standard applies to cardiopulmonary bypass system used in the extracorporeal circulation of the pipeline and its associated with the auxiliary pipeline, the product in the cardiovascular

Surgery for extracorporeal circulation as a blood channel and channel connection used for one-time use.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191 packaging and storage icon

GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 1. General requirements

GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 2. Locking joints

Standard Test Method for Drinking Water of Metals - Metals Indicators GB/T 5750.6-2006

General rules for the use of industrial products GB/T 9969

GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods

GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management

GB 18279 Sterilization and routine control of ethylene oxide for medical devices

GB 18280 Health care products Sterilization confirmation and routine control requirements Radiation sterilization

General technical conditions for disposable blood use products GB 19335-2003

Packaging, marking, transportation and storage of medical polymer products YY/T 0313-1998

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic

Claim

Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing YY/T 0681.1-2009

Classification and composition 3.1 pipeline generally by the pipeline, joints, pump and other components.

3.2

Pipes are generally divided into 4.8mm (3/16 "), 6.3mm (1/4"), 9.5mm (3/8 "), 12.7mm (1/2") and other specifications

Grid is specified by the manufacturer).

3.3

connector is generally divided into three links, through joints, side hole through joints and so on.

4 requirements

4.1 appearance

4.1.1

pipeline should be translucent or transparent, inside and outside the surface should be smooth, plastic uniform, no kink, the end should be neat no cracks.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.

Referenced standards

Normative references

GB 18280 · GB 19335-2003

Similar standards

YY/T 0962|YY 1271|YY 0948|YY/T 1274

Editions of YY 1048

Edition	Title	Revision	Status
YY 1048-2016	Cardiopulmonary bypass systems - Extracorporeal blood circuit	current edition	Current
YY 1048-2007	Cardiopulmonary bypass systems - Extracorporeal blood circuit	previous edition	In force until 2018-01-01

This page sells the current edition, YY 1048-2016. Earlier editions are listed for reference only.

How to Download YY 1048-2016

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.