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YY 0450.2-2003Accessory devices for sterile single-use intravascular catheters - Part 2: Obturators for over-needle peripheral catheters (English PDF)

一次性使用无菌血管内导管辅件第2部分：套针外周导管管塞

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

February 9, 2003

Implementation date

September 1, 2003

Scope

YY 0450.2-2003 is the English-translated version of 一次性使用无菌血管内导管辅件第2部分：套针外周导管管塞.

YY 0450.2-2003 is the Chinese standard "Accessory devices for sterile single-use intravascular catheters - Part 2: Obturators for over-needle peripheral catheters".

Its scope clause reads: This part of YY 0450 specifies requirements for obturators, supplied in the sterile condition and intended for single use for plugging over-needle peripheral catheters.

Note: Attention is drawn to YY 0285.5, which specifies requirements for over-needle peripheral catheters. Its clauses include definitions.

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Document preview — YY 0450.2-2003

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (Normative) Method for determining force at break of the obturator
Annex B (Informative) Bibliography

1 Scope

This part of YY 0450 specifies requirements for obturators, supplied in the sterile condition and intended for single use for plugging over-needle peripheral catheters.

Note: Attention is drawn to YY 0285.5, which specifies requirements for over-needle peripheral catheters.

2 Normative references

The following normative documents contain provisions which, through reference of YY 0450, constitute provisions of this part. For dated reference, subsequent amendments to (excluding correction), or revisions, of any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest editions apply to this part.

GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001; idt ISO 594-1: 1986)

GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001; idt ISO 594-2: 1998)

3 Definitions

For the purposes of this part, the following terms and definitions apply.

3.1 obturator

device designed to be inserted into an over-needle peripheral catheter to plug the lumen of the catheter

See figure 1.

1—— Outside diameter;

2——Tip;

3——Effective length;

4——Luer fitting (locking fitting shown);

5——Obturator shaft.

Figure 1 Example of obturator […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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YY 0285.5-2018|YY 0450.1-2020|YY/T 0450.3-2016|YY 0489-2004|YY 0285.1-2017|YY 0285.3-2017

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