THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS ORDER No. 59

Polymer Urethral Catheters for General Medical use

I, John Cable, delegate of the Minister for Health and Family Services for the purposes of the exercise of the Minister’s powers under Section 10 of the Therapeutic Goods Act 1989, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY:

REVOKE, on and from the date this Order is gazetted, Therapeutic Goods Order No, 38, “Single-Use Urethral Catheters (Sterile) for General Medical Use” which commenced to operate on 16 May 1991; and

DETERMINE that the matters specified in clauses 1 to 10 inclusive and Appendix A and B in the document titled “AS/NSZ 2696:1996 Australian/New Zealand Standard, Medical devices – Polymer urethral catheters for general medical use”, published by Standards Australia on 5 July 1996 (“the Standard”) and as modified below, shall constitute standards for all polymer urethral catheters for general medical use.

MODIFICATIONS TO THE STANDARD

(a)	CLAUSE 2 “REFERENCED DOCUMENTS”
Add to the top of the list of referenced documents in Clause 2 the Australian Standard: 

      “1199 Sampling procedures and tables for inspection by attributes (AS 1199-1988)”;

(b)	NEW CLAUSE 11
   	Insert after Clause 10 the following new Clause:

“11	The table below sets out the acceptable quality levels to be applied to the tests described in the standard, as set out in “Table 1 - Sample size code letters” and   “Table 2-A - Single sampling plans for normal inspection (Master table)” in AS 1199.”;

AS/NZS
2696:1996
Clause No.	Inspection Level	  Acceptable Quality Level	
    6.4.2	   A minimum of 3 replicates shall be 
  used for the test samples and controls
   used to test for cytotoxicity, refer to 
                       Appendix B		
   6.4.4	As defined in TGO 11	    As defined in TGO 11	
   7.2.1.	S-2	4.0	
   7.2.2	S-2	4.0	
     7.3	S-2	4.0	
   8.1.2	S-2	4.0	
   8.1.4	S-2	4.0	
   8.1.5	S-2	1.5	

   8.2.2	S-2	4.0	
   8.2.5	S-2	1.5	
   8.2.6	S-2	4.0	
   8.2.7	S-2	1.5	
   8.2.8	S-2	4.0	
   8.2.9	S-2	1.5	
     9.1	S-2	1.5	
   10.1	S-2	1.5	
   10.2	S-2	1.5	
   10.3	S-2	1.5	

(c)		NEW CLAUSE 12
            Insert after Clause 11 the following new Clause:

	“12   A reference in this Order to another document is taken to be a reference to the document as in force on the date this Order is gazetted.”.

This Order commences on the date this Order is gazetted.

Dated on this 7th day of April 1997.

John Cable
Delegate of the Minister for Health and Family Services