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LOCAL GOVERNMENT AND PUBLIC HEALTH. THE THERAPEUTIC SUBSTANCES (SAORSTÁT EIREANN) (AMENDMENT) REGULATIONS, 1935. The Minister for Local Government and Public Health in exercise
the powers conferred on him by the Therapeutic Substances Act, 1932 , does by this his Order, after consultation with the Therapeutic Substances Advisory Committee, order as follows:— 1 .. 1.—
these Regulations, relating to sterilised surgical catgut, shall come into operation on the 1st day
November, 1935, but save as aforesaid these Regulations shall come into operation on the date hereof.
binding material prepared from gut or other animal tissue and
fered or intended to be
fered for sale as sterile and ready for use in surgical operations upon the human body, being a therapeutic substance the purity
which cannot in the opinion
the Minister be adequately tested by chemical means is hereby declared to be a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies. 3 .. 3.—
the Principal Regulations which relate to licences for manufacture other than sub-paragraphs (b) and (i)
thereof shall apply to the manufacture
sterilised surgical catgut.
sterilised surgical catgut shall, in addition to being subject to the conditions set forth in Article 5
the Principal Regulations, as applied by these Regulations, be subject to the further condition that the licensee shall comply with the provisions
these Regulations and with such further requirements, if any, as may be specified in any regulations which may be made under the Therapeutic Substances Act, 1932 , and
which the Minister has given the licensee not less than one month's notice. 4 .. 4. Sterilised surgical catgut shall not be sold or
fered for sale unless it has been sealed in a previously sterilised container or packet, in such manner, as will, in the opinion
the Minister, suffice to preclude the access
bacteria. 5 .. 5. If any sterilised surgical catgut is advertised or sold as such, the name "Sterilised surgical catgut" shall appear on the label
the container or packet in the manner prescribed in Article 8
the Principal Regulations: Provided that— (
paragraph
paragraph
the Principal Regulations ; and (ii) for the purpose
sub-paragraph (c)
paragraph
the said Article 8, the date on which the test for sterility hereinafter prescribed in these Regulations was completed, shall be treated as the date on which the manufacture
the batch
catgut was completed. 6 .. 6. Before any sterilised surgical catgut is sold or
fered for sale, the batch to which it belongs shall have been tested for the presence
living bacteria in the manner specified in the Schedule to these Regulations by the manufacturer or by some institution approved by the Minister for the purpose on his behalf and none
the contents
the batch shall be sold or
fered for sale unless the batch has passed the test. 7 .. 7. The provisions
Parts V and VII
the Principal Regulations which relate respectively to licences for the import
therapeutic substances and to therapeutic substances manufactured or imported for export only shall apply to sterilised surgical catgut. 8 .. 8. For the purpose
these Regulations a batch
catgut shall consist entirely
material collected under uniform conditions and simultaneously subjected or intended to be subjected to the same process or series or processes for rendering it sterile. 9 .. 9. Save as in these Regulations expressly provided, the provisions
the Principal Regulations shall not apply to sterilised surgical catgut. AMENDMENT
PRINCIPAL REGULATIONS. 10 .. 10. The following amendments shall be made in the Principal Regulations:— (a) In sub-paragraph
(B)
the Second Schedule the words "These determinations shall be made as follows :—A sample
the vaccine lymph shall be thoroughly mixed with melted nutrient agar medium and a culture plate poured from the mixture, or the sample shall be spread upon the surface
a prepared plate
nutrient agar. The number
colonies appearing on incubation for two days at approximately 37°C. and then for at least three days at approximately 20°C. shall then be enumerated." shall be substituted for the words from "These determinations" to the figures and letter "20°C." (b) In sub-paragraph
(B)
the Second Schedule, the figures "100" shall be substituted for the figures "1000" and in sub-paragraph
the said Article, the word "hundredfold" shall be substituted for the word "thousandfold." (c) In Article 3
(A)
the Second Schedule and in the heading
that Article the word and figures "Article 19" shall be substituted for the word and figures "Article 18." SCHEDULE. METHOD
CARRYING OUT TEST FOR STERILITY. 1. For the purposes
the test a sample
catgut shall be taken from each batch consisting
not less than 1 per cent.
the whole quantity
material constituting the batch. The sample shall, when practicable, be the contents
at least one whole container or packet, and shall be drawn at random from the whole number
containers or packets constituting the batch. 2. The sample shall be subjected to the following processes for testing its sterility :— (
f as completely as possible, the sample shall be placed entire in a test tube at least 3’5 cms. in diameter, and 17’5 cms. in length, and containing 50 mils
sterile distilled water. This tube shall then be closed by some method which will preclude the access
bacteria, and placed in an incubator at 37°C. for 24 hours. (c) After this incubation, the sample shall be aseptically transferred to a similar tube containing a solution
1 per cent.
sodium thiosulphate and 1 per cent.
sodium carbonate in distilled water, the tube and solution having been previously sterilised in the autoclave. In this solution the sample shall again be incubated for 24 hours at 37°C. (d) After the second incubation the sample shall be again removed aseptically and, without further washing, shall be examined for the presence
living bacteria and their spores. The sterility tests shall be carried out either— (i) by placing the sample in a tube at least 3’5 cms. in diameter and 17’5 cms. in length, containing not less than 50 mils
a culture medium prepared by dissolving 0’2 per cent.
prepared agar-agar in a nutrient bacteriological broth,* the mixture being sterilised in the autoclave ; or (ii) by the method prescribed in Articles 16
the Principal Regulations : Provided that, if a manufacturer satisfies the Minister that he has already in use tests for the purpose
living aerobic or anaerobic bacteria, and that these tests, as applied by him, will detect the presence
such bacteria in the catgut as ready for issue with a certainty at least equal to that afforded by the application
the tests prescribed in the above-mentioned Articles, the Minister may approve the use
such tests in the place
the tests so prescribed ; but, in that event, the Minister may at any time withdraw such approval and require the manufacturer to carry out the prescribed tests. (e) The tubes
culture medium containing the sample shall be incubated at 37°C. for 12 days, and examined daily for the growth
bacteria. *Note—The broth may preferably be made by the digestion
meat with trypsin (Douglas' broth or Hartley's modification thereof). (f) If no such growth is detected during this period, the batch from which the sample was drawn shall be treated as free from living bacteria and their spores, and as having passed the test. Given under the
ficial Seal
the Minister for Local Government and Public Health, this Twenty-seventh day
September, One Thousand Nine Hundred and Thirty-five. (Sighnithe) SEÁN T. O'CEALLAIGH, Minister for Local Government and Public Health. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government
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