Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 1-36: ISO 5366-3:2001 Second edition 2001-08-15, Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes -- Part 3: Pediatric Tracheostomy Tubes. (Anesthesias)

Date of Standard: 2001.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF COMPLIANCE (OC)

(2)	OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
	DIVISION OF POSTMARKET SURVEILLANCE (DPS)

(3)	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Tracheostomy Tubes Made of Elastomeric and/or Rubber Materials and Connectors

Processes Affected:

Vigilance Reporting

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard and any annexes with the following exceptions:

Clause 6.1. Information related to the resistance to cleaning, disinfection, and sterilization agents should be provided, including a description of test methods, acceptance criteria, and results. For those devices that use ethylene oxide as a sterilant, the residue levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol shall not exceed 250 ppm, 250 ppm, and 5000 ppm, respectively.

Clause 4.3. is recognized with clarification. Because the device is considered to have permanent-duration contact with tissue and mucosal membrane, the device is considered external communicating, and reports of cytotoxicity, sensitization, genotoxicity, and implantation testing should be provided as indicated in ISO 10993-1. All biocompatibility test should be performed after the device has been sterilized initially (for products provided sterile) or after recommended sterilization procedure.

Clause 4.6. is not recognized. ASTM F 1242-96, Section 5.1 applies.

Clause 7.1 is not recognized. 21 CFR 801.15(c)(1) states that all words, statements, and other information required by the Act to appear on the label or labeling shall appear in the English language. English labeling allows immediate and positive verification for the proper use of medical equipment. As outlined in 21 CFR 807.87(e), proposed labels and labeling shall be sufficient to describe the directions for use of the device, and Section 502(f) of the Act requires adequate directions for use. All device labeling should contain English text adjacent to any icons/symbols used if space permits. If space does not permit, the icon/symbols should be replaced with English text only.

Clause 7.2.1.1b is recognized in part. Markings on trachel tubes which indicates inner or outer diameter should be accompanied by text or letters identifying the numbers as diameters.

ASTM F 1242-96, Section 5.1 and A1.3 (cuff symmetry test) and ASTM F 1242-96, Section 5.3 and A1.7 (leak test) also apply.

Annex D.1.1 Information related to the tube rigidity characteristics shall be provided, including a description of the test methods and results.

Related CFR Citations and Product Codes:



Regulation Number	Device Name	Device Class	Product Code
§868.5800	Tube Tracheostomy And Tube Cuff	Class 2	JOH
§868.5800	Tube, Tracheostomy (W/Wo Connector)	Class 2	BTO