(iv) uses an established molecular detection method;  (c) any device used for the purposes of the test—  (i) can be put into service in accordance with Part 4 of the Medical Devices Regulations  2002, other than solely by virtue of regulation 39(2) of those Regulations,  (ii) has been validated no more than 18 months before the test is administered or  provided to P;  (e) the test provider complies with paragraph 3.  (d) it is not a test provided or administered under the National Health Service Act 2006, the  National Health Service (Wales) Act 2006( a ), the National Health Service (Scotland) Act  1978( b ), or the Health and Personal Social Services (Northern Ireland) Order 1972( c );  and  (iii) a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre,  and  (a) the Secretary of State;  (b) a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025( d )  by—  (i) the United Kingdom Accreditation Service( e ) (“UKAS”), or  (ii) an accreditation body that is a signatory to the International Laboratory Accreditation  Cooperation (“ILAC”) Mutual Recognition Arrangement( f ) or the European co- operation for Accreditation (“EA”) Multilateral Agreement( g ),  (c) a laboratory which is accredited by UKAS to ISO standard 15189 or ISO/IEC standard  17025( i ), other than a laboratory which processes tests provided by the test provider for  the purposes of this Schedule or is owned by the test provider or the device manufacturer.  (2) For the purposes of sub-paragraph (1), “validated”, in relation to a device, means confirmed  as having the required sensitivity and specificity using at least 150 positive clinical samples and  250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the  performance specification of the target product profile published by the Medicines and Healthcare  Products Regulatory Agency for laboratory based SARS-CoV-2 PCR tests, by—  other than a laboratory which processes tests provided by the test provider for the  purposes of this Schedule or is owned by the test provider or the device manufacturer.  ( h ); or  ( a )  2006 c. 42.  ( b ) 1978 c. 29.  ( c )  S.I. 1972/1265 (N.I. 14).  ( d ) ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their  website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de  Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO/IEC 17025 General requirements for the competence of  testing and calibration laboratories was published in November 2017.  ( e )  The United Kingdom Accreditation Service is a company limited by guarantee incorporated in England and Wales under  number 3076190.  ( f )  ILAC is an international organisation which coordinates the work of its signatory national accreditation bodies which are  themselves involved in the accreditation of conformity assessment bodies, testing laboratories, and medical testing  laboratories.  ( g )  EA is a regional organisation which coordinates the work of its signatory national accreditation bodies. EA is recognised by  and works closely with ILAC. ( h ) A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).  ( i )  ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their  website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de  Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO/IEC 17025 General requirements for the competence of  testing and calibration laboratories was published in November 2017. ISO 15189 Medical Laboratories requirements for  quality and competence was published in November 2012.  69