YY 0285.3-2017Intravascular catheters—Sterile and single-use catheters - Part 3: Central venous catheters (English PDF)
血管内导管一次性使用无菌导管 第3部分：中心静脉导管
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
July 17, 2017
Implementation date
January 1, 2019
Scope
YY 0285.3-2017 is the English-translated version of 血管内导管一次性使用无菌导管 第3部分：中心静脉导管.
YY 0285.3-2017 is the Chinese pharmaceutical industry standard for the central venous catheter supplied sterile for single use.
It is the third part of the YY 0285 series and sets the requirements particular to such catheters on top of the general part, covering the dimensions and the number and arrangement of the lumens, the flow rate of each lumen, the radiopacity, the strength of the catheter, of the hub and of the extension lines, the freedom from leakage, the materials and their biological evaluation, and sterility, together with the information supplied with the device. Issued on 17 July 2017, it has applied since 1 January 2019.
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Document preview — YY 0285.3-2017
National Standard of the People's Republic of China
- Replacing
- YY 0285.3-1999
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 Requirements5
Foreword
YY 0285 "Intravascular catheters - Sterile and single-use catheters" consists of four parts.
- Part 1. General requirements;
- Part 3. Central venous catheters;
- Part 4. Balloon dilatation catheters;
- Part 5. Over-needle peripheral catheters. This Part is Part 3 of YY 0285.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0285.3-1999 "Sterile single-use intravascular catheters - Part 3. Central venous catheters". Compared with YY 0285.3-1999, the main technical changes are as follows.
- updated the normative references;
- deleted Annex A.
This Part uses redrafting method to modify and adopt ISO 10555-3:2013 "Intravascular catheters - Sterile and single-use catheters - Part 3. Central venous catheters".
The technical differences and reasons between this Part and ISO 10555-3:2013 are as follows.
- about normative references, this Standard made an adjustment on technical differences so as to adapt to the technical conditions in China; see Clause 2 "Normative references" for the adjustment, as follows.
- replaced ISO 10555-1:2013 with YY 0285.1-2017 that modified and adopted the International standard.
1 Scope
This Part specifies the requirements for sterile and single-use central venous catheter.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY 0285.1-2017, Intravascular catheters - Sterile and single-use catheters - Part 1. General requirements (ISO 10555-1:2013, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in YY 0285.1-2017 and the followings apply.
3.1 Central venous catheter
a central venous system is inserted for intravascular catheters for the delivery of fluids or blood samples and/or for pressure or other measurements, and is divided into single chambers or multiple chambers
NOTE The catheter may have a fixation system as an integral part of the instrument.
4 Requirements
4.1 General
The catheter shall comply with the requirements of YY 0285.1-2017 except for peak tension (see YY 0285.1-2017, 4.6). The peak tension shall meet the requirements of 4.4.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY 0285.3
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0285.3-2017 | Intravascular catheters—Sterile and single-use catheters - Part 3: Central venous catheters | current edition | Current |
| YY 0285.3-1999 | Intravascular catheters—Sterile and single-use catheters - Part 3: Central venous catheters | previous edition | Superseded |
This page sells the current edition, YY 0285.3-2017. Earlier editions are listed for reference only.
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Related Standards
YY 0285.1-2017 — Intravascular catheters—Sterile and single-use catheters - Part 1: General requirements
YY 0285.4-2017 — Intravascular catheters—Sterile and single-use catheters - Part 4: Balloon dilatation catheters
YY 0285.2-1999 — Sterile single-use intravascular catheters - Part 2: Angiographic catheters
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YY 0285.3-2017
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