YY/T 0339-2019 English PDF (YYT0339-2019)

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YY/T 0339-2019: Suction catheters for use in the respiratory tract
YY/T 0339-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Replacing YY 0339-2009
Suction Catheters for Use in the Respiratory Tract
(ISO 8836:2014, MOD)
ISSUED ON: MAY 31, 2019
IMPLEMENTED ON: JUNE 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
Introduction ... 7
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 10
4 General Requirements for Open and Closed Suction Catheters* ... 14
4.1 Risk management ... 14
4.2 Safety ... 14
5 Specific Requirements for Open and Closed Suction Catheters ... 15
5.1 Size and length designations ... 15
5.2 Dimensions* ... 16
6 Materials ... 16
7 Design ... 17
7.1 Lumen of the suction catheter ... 17
7.2 Suction catheter tip ... 17
7.3 Suction catheter connector ... 18
7.4 Additional requirements for closed suction catheters ... 19
7.4.1 General design ... 19
7.4.2 Patient end adaptor and connectors for the closed suction catheter ... 20
7.4.3 Protective sleeve ... 21
7.4.4 Vacuum control device for closed suction catheters ... 22
7.4.5 Flushing system for closed suction catheters ... 22
7.4.6 T-piece cap ... 22
8 Performance Requirements ... 22
8.1 Security of construction ... 22
8.2 Shaft performance ... 23
8.3 Vacuum control device performance* ... 23
8.4 Leakage*... 23
8.5 Resistance to flow* ... 24
8.6 Radiopacity* ... 24
9 Requirements for Suction Catheters Supplied Sterile ... 24
9.1 Sterility assurance ... 24
9.2 Packaging of suction catheters supplied sterile ... 24
10 Marking ... 25
10.1 Marking on suction catheters ... 25
10.2 Use of symbols ... 26
10.3 Labelling of individual packs ... 26
10.4 Labelling of shelf/multi-unit packs... 27
Annex A (Informative) Rationale ... 29
Annex B (Normative) Test Method for Security of Attachment ... 33
Annex C (Normative) Measurement of Residual Vacuum ... 34
Annex D (Normative) Method of Testing Leakage... 36
Annex E (Informative) Hazard Identification for Risk Assessment ... 37
Bibliography ... 40
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY 0339-2009 Suction Catheters for Use in the Respiratory
Tract. Compared with YY 0339-2009, the major technical changes besides the editorial
modifications of this Standard are as follows:
--- Add the requirements for the closed suction catheter (see 7.4 of this Standard);
--- Modify the requirements for the therapy ventilator (see 8.4 and 8.5 of this
Standard);
--- Modify the requirements for the risk management (see 4.1 of this Standard);
--- According to ISO 8836, correct the instructions for the Positions 1 and 2 in Figure
C.1 (see Figure C.1 of this Standard; Figure B.1 in YY 0339-2009).
This Standard uses the re-drafting method to modify and adopt the international
standard ISO 8836:2014 Suction Catheters for Use in the Respiratory Tract (English
Version).
Compared with ISO 8836:2014, the major technical differences of this Standard are as
follows:
--- Regarding the normative references, this Standard made the adjustments in
technical differences, so as to adapt to China’s technical conditions. The
adjustments were centrally reflected in Clause 2 “Normative References”; the
specific adjustments are as follows:
⚫ Use the national standard GB/T 1962.1 to replace the international standard
ISO 594-1 (see 7.4.5);
⚫ Use the national standard GB/T 1962.2 to replace the international standard
ISO 594-2 (7.4.5);
⚫ Use the national standard GB/T 4999 to replace the international standard
ISO 4135:2001 (see Clause 3);
⚫ Use the national standard GB/T 9706.1 to replace the international standard
IEC 60601-1:2005 (see 10.2);
⚫ Use the national standard GB/T 16273.1 to replace the international
standard of ISO 7000 (see 10.2);
⚫ Use the national standard GB/T 16886.1 to replace the international
standard ISO 10993-1 (see 6.1);
⚫ Use the national standard GB/T 19633.1 to replace the international
standard ISO 11607-1 (see 9.2.2);
⚫ Use the national standard GB/T 19633.2 to replace the international
standard ISO 11607-2 (see 9.2.2);
⚫ Use the industry standard YY/T 0316 to replace the international standard
ISO 14971:2007 (see 4.1.1);
⚫ Use the industry standard YY/T 0466.1 to replace the international standard
ISO 15223-1 (see 10.2);
⚫ Use the industry standard YY/T 0466.2 to replace the international standard
ISO 15223-2 (see 10.2);
⚫ Use the industry standard YY 0636.1 to replace the international standard
ISO 10079-1 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY 0636.2 to replace the international standard
ISO 10079-2 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY 0636.3 to replace the international standard
ISO 10079-3 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY/T 1040.1 to replace the international standard
ISO 5356-1 (see 7.3.5, 7.4.2.1 and 7.4.2.2).
Compared with ISO 8836:2014, the editorial modifications of this Standard are as
follows:
--- The instructions of major differences between ISO 8836:2014 and the former
edition are transferred to this Foreword;
--- Correct the editorial errors in ISO 8836:2004;
⚫ Change the sub-clause number from 7.3.6, 7.3.7 and 7.3.8 to 7.3.5, 7.3.6,
and 7.3.7;
⚫ Transfer the normative reference ISO 4135:2001 from the Bibliography to
Clause 2 Normative References;
⚫ Transfer the non-normative reference IEC 62366-1 from Clause 2 Normative
References to the Bibliography; which is replaced by the corresponding
industry standard YY/T 1474.
Suction Catheters for Use in the Respiratory Tract
1 Scope
This Standard specifies requirements for suction catheters, including open and closed
suction catheters, made of flexible materials and intended for use in suctioning of the
respiratory tract.
Angled-tip suction catheters (e.g.: catheters) and suction catheters with
aspirator collectors are not considered to be specialized and are therefore included in
the scope of this Standard.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers
or electrical surgical equipment are not covered by this Standard.
NOTE: See ISO/TR 11991 [6] for guidance on airway management during laser surgery of the
upper respiratory tract.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
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-
2015, ISO 594-1:1986, IDT)
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, ISO
594-2:1998, IDT)
GB/T 4999 Anaesthetic and respiratory equipment – Vocabulary (GB/T 4999-
2003, ISO 4135:2001, IDT)
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for
Safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)
GB/T 16273.1 Graphical Symbols for Use on Equipment - Part 1: Common
Symbols (GB/T 16273.1-2008, ISO 7000:2004, NEQ)
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Eva...