Chapter 6.2

  6.2.1.3.6.5.4 Amend the footnote to read as follows:

  "*See for example CGA Publications S-1.2-2003 "Pressure Relief Device Standards - Part 2 - Cargo and Portable Tanks for Compressed Gases" and S-1.1-2003 "Pressure Relief Device Standards - Part 1 - Cylinders for Compressed Gases".".

  6.2.1.4.1.10 Amend "porous mass" to read "porous material".

  6.2.1.5.1 Amend subparagraph .3 to read as follows:

  ".3 Check of the threads if there is evidence of corrosion or if the fittings are removed;"

 Amend the end of Note 2 under subparagraph .4 to read as follows:

 "… based on acoustic emission testing, ultrasonic examination or a combination of acoustic emission testing and ultrasonic examination.".

  6.2.1.5.2 Amend "porous mass" to read "porous material".

  6.2.2.1.1 Insert the following new entry at the end of the table:

  6.2.2.1.3 In the table, under "For the cylinder shell:", delete the reference to ISO 7866:1999. Amend "porous mass" to read "porous material".

  6.2.2.1.4 Add a new paragraph to read as follows:

  "6.2.2.1.4 The following standard applies for the design, construction and initial inspection and test of UN cryogenic receptacles, except that inspection requirements related to the conformity assessment system and approval shall be in accordance with 6.2.2.5:

  6.2.2.5.2.1 Amend "6.2.2.6" and "6.2.2.7" to read "6.2.2.7" and "6.2.2.8" respectively at the end of the first paragraph.

  6.2.2.5.3.1 In .1, insert "of personnel" after "responsibilities" and delete ", and power of the management". Delete the "," and insert "and" between "structure" and "responsibilities".

 In .2, replace "systematic actions" with "procedures".

 Delete the commas before "and" in .3 and .4.

  6.2.2.5.4.10 Amend to read as follows:

  "6.2.2.5.4.10 Modifications to approved design types

 The manufacturer shall either:

• (a) inform the issuing competent authority of modifications to the approved design type, where such modifications do not constitute a new design, as specified in the pressure receptacle standard; or

• (b) request a subsequent design type approval where such modifications constitute a new design according to the relevant pressure receptacle standard. This additional approval shall be given in the form of an amendment to the original design type approval certificate.".

  6.2.2.7.2 In (g) add the following new last sentence at the end of the existing text:

 "In the case of pressure receptacles for UN 1001 acetylene, dissolved and UN 3374 acetylene, solvent free, at least one decimal shall be shown after the decimal point and two digits for pressure receptacles of less than 1 kg;".

 In (k) and (l): Insert ", any coating," after "during filling" and replace "two" with "three" in the first sentence. Insert the following new last sentence at the end of the existing text:

 "At least one decimal shall be shown after the decimal point. For pressure receptacles of less than 1 kg, the mass shall be expressed to two significant figures rounded down to the last digit;".

  6.2.2.7.2 (g), (k) and (l) Amend "porous mass" to read "porous material".

  6.2.2.7.7 Add the following new paragraph:

  "6.2.2.7.7 For acetylene cylinders, with the agreement of the competent authority, the date of the most recent periodic inspection and the stamp of the body performing the periodic inspection and test may be engraved on a ring held on the cylinder by the valve. The ring shall be configured so that it can only be removed by disconnecting the valve from the cylinder.".

  6.2.4 Renumber current paragraphs 6.2.4.1 and 6.2.4.2 as 6.2.4.1.1 and 6.2.4.1.2 respectively and insert a new 6.2.4.1 to read as follows:

  "6.2.4.1 Small receptacles containing gas (gas cartridges)"

 Add the following new paragraphs:

  "6.2.4.2 Aerosol dispensers

Each filled aerosol dispenser shall be subjected to a test performed in a hot water bath or an approved water bath alternative.

  6.2.4.2.1 Hot water bath test

  6.2.4.2.1.1 The temperature of the water bath and the duration of the test shall be such that the internal pressure reaches that which would be reached at 55°C (50°C if the liquid phase does not exceed 95% of the capacity of the aerosol dispenser at 50°C). If the contents are sensitive to heat or if the aerosol dispensers are made of plastics material which softens at this test temperature, the temperature of the bath shall be set at between 20°C and 30°C but, in addition, one aerosol dispenser in 2000 shall be tested at the higher temperature.

  6.2.4.2.1.2 No leakage or permanent deformation of an aerosol dispenser may occur, except that a plastic aerosol dispenser may be deformed through softening provided that it does not leak.

  6.2.4.2.2 Alternative methods

With the approval of the competent authority alternative methods which provide an equivalent level of safety may be used provided that the requirements of 6.2.4.2.2.1, 6.2.4.2.2.2 and 6.2.4.2.2.3 are met.

  6.2.4.2.2.1 Quality system

Aerosol dispenser fillers and component manufacturers shall have a quality system. The quality system shall implement procedures to ensure that all aerosol dispensers that leak or that are deformed are rejected and not offered for transport.

 The quality system shall include:

• (a) a description of the organizational structure and responsibilities;

• (b) the relevant inspection and test, quality control, quality assurance, and process operation instructions that will be used;

• (c) quality records, such as inspection reports, test data, calibration data and certificates;

• (d) management reviews to ensure the effective operation of the quality system;

• (e) a process for control of documents and their revision;

• (f) a means for control of non-conforming aerosol dispensers;

• (g) training programmes and qualification procedures for relevant personnel; and

• (h) procedures to ensure that there is no damage to the final product.

An initial audit and periodic audits shall be conducted to the satisfaction of the competent authority. These audits shall ensure the approved system is and remains adequate and efficient. Any proposed changes to the approved system shall be notified to the competent authority in advance.

  6.2.4.2.2.2 Pressure and leak testing of aerosol dispensers before filling

Every empty aerosol dispenser shall be subjected to a pressure equal to or in excess of the maximum expected in the filled aerosol dispensers at 55°C (50°C if the liquid phase does not exceed 95% of the capacity of the receptacle at 50°C). This shall be at least two-thirds of the design pressure of the aerosol dispenser. If any aerosol dispenser shows evidence of leakage at a rate equal to or greater than 3.3 × 10^-2 mbar.l.s^-1 at the test pressure, distortion or other defect, it shall be rejected.

  6.2.4.2.2.3 Testing of the aerosol dispensers after filling

Prior to filling, the filler shall ensure that the crimping equipment is set appropriately and the specified propellant is used.

Each filled aerosol dispenser shall be weighed and leak tested. The leak detection equipment shall be sufficiently sensitive to detect at least a leak rate of 2.0 × 10^-3 mbar.l.s^-1 at 20°C.

Any filled aerosol dispenser which shows evidence of leakage, deformation or excessive weight shall be rejected.".

  6.2.4.3 Add a new paragraph to read as follows:

  "6.2.4.3 With the approval of the competent authority, aerosols and receptacles, small, containing pharmaceutical products and non flammable gases which are required to be sterile, but may be adversely affected by water bath testing, are not subject to 6.2.4.1 and 6.2.4.2 if:

• (a) They are manufactured under the authority of a national health administration and, if required by the competent authority, follow the principles of Good Manufacturing Practice (GMP) established by the World Health Organization (WHO)^footnote; and

• (b) An equivalent level of safety is achieved by the manufacturer's use of alternative methods for leak detection and pressure resistance, such as helium detection and water bathing a statistical sample of at least 1 in 2000 from each production batch.".