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YY/T 0339-2019Suction catheters for use in the respiratory tract (English PDF)

呼吸道用吸引导管

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 31, 2019

Implementation date

June 1, 2020

Scope

YY/T 0339-2019 is the English-translated version of 呼吸道用吸引导管.

YY/T 0339-2019 is the Chinese standard "Suction catheters for use in the respiratory tract". Its scope clause reads: 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.

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Document preview — YY/T 0339-2019

National Standard of the People's Republic of China

Replacing: YY 0339-2009

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

Foreword4
Introduction7
1 Scope8
2 Normative References8
3 Terms and Definitions10
4 General Requirements for Open and Closed Suction Catheters*14
4.1 Risk management14
4.2 Safety14
5 Specific Requirements for Open and Closed Suction Catheters15
5.1 Size and length designations15
5.2 Dimensions*16
6 Materials16
7 Design17
7.1 Lumen of the suction catheter17
7.2 Suction catheter tip17
7.3 Suction catheter connector18
7.4 Additional requirements for closed suction catheters19
7.4.1 General design19
7.4.2 Patient end adaptor and connectors for the closed suction catheter20
7.4.3 Protective sleeve21
7.4.4 Vacuum control device for closed suction catheters22
7.4.5 Flushing system for closed suction catheters22
7.4.6 T-piece cap22
8 Performance Requirements22
8.1 Security of construction22
8.2 Shaft performance23
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 Sterile24
9.1 Sterility assurance24
9.2 Packaging of suction catheters supplied sterile24
10 Marking25
10.1 Marking on suction catheters25
10.2 Use of symbols26
10.3 Labelling of individual packs26
10.4 Labelling of shelf/multi-unit packs27
Annex A (Informative) Rationale29
Annex B (Normative) Test Method for Security of Attachment33
Annex C (Normative) Measurement of Residual Vacuum34
Annex D (Normative) Method of Testing Leakage36
Annex E (Informative) Hazard Identification for Risk Assessment37
Bibliography40

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.Evaluation and

Testing within a Risk Management Process (GB/T 16886.1-2011, ISO 10993-

1.2009, IDT)

GB/T 19633.1 Packaging for Terminally Sterilized Medical Devices - Part 1.

Requirements for Materials, Sterile Barrier Systems and Packaging Systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT)

GB/T 19633.2 Packaging for Terminally Sterilized Medical Devices - Part 2.

Validation Requirements for Forming, Sealing and Assembly Processes (GB/T 19633.2-2015, ISO 11607-2.2006, IDT)

YY/T 0316 Medical Devices - Application of Risk Management to Medical

Devices (YY/T 0316-2016, ISO 14971.2007, IDT)

YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels,

Labelling and Information to be Supplied - Part 1.General Requirements (YY/T 0466.1-2016, ISO 15223-1.2007, IDT)

YY/T 0466.2 Medical Devices - Symbols to be Used with Medical Device Labels,

Labelling and Information to be Supplied - Part 2.Symbol Development, Selection and Validation (YY/T 0466.2-2015, ISO 15223-2.2010, IDT)

YY 0636.1 Medical Suction Equipment - Part 1.Electrically Powered Suction

Equipment - Safety Requirements (YY 0636.1-2008, ISO 10079-1.1999, MOD)

YY 0636.2 Medical Suction Equipment - Part 2.Manually Powered Suction

Equipment (YY 0636.2-2008, ISO 10079-2.1999, IDT)

YY 0636.3 Medical Suction Equipment - Part 3.Suction Equipment Powered from a Vacuum or Pressure Source (YY 0636.3-2008, ISO 10079-3.1999, IDT)

YY/T 1040.1 Anaesthetic and Respiratory Equipment - Conical Connectors - Part

1 Cones and Sockets (YY/T 1040.1-2015, ISO 5356-1.2004, IDT)

ISO 5367.2014 Anaesthetic and Respiratory Equipment - Breathing Sets and

Connectors

ISO 11135 Sterilization of Health-Care Products - Ethylene Oxide -

Requirements for the Development, Validation and Routine Control of a

Sterilization Process for Medical Devices

ISO 11137-1 Sterilization of Health-Care Products - Radiation - Part 1.

Requirements for Development, Validation and Routine Control of a Sterilization

Process for Medical Devices

ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good

YY/T 0490-2017 | YY/T 0506.2-2016 | YY/T 0506.1-2005 | YY/T 0337-2025 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 40 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 11135 · ISO 11137-1 · ISO 14155

Editions of YY/T 0339

Edition	Title	Revision	Status
YY/T 0339-2019	Suction catheters for use in the respiratory tract	current edition	Current
YY 0339-2009	Suction catheters for use in the respiratory tract	previous edition	Superseded

This page sells the current edition, YY/T 0339-2019. Earlier editions are listed for reference only.

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