This Part of CEN\/TS 14507 refers to EN 60601\u20111:1990 “Medical electrical equipment \u2014<\/i> Part 1: General requirements for safety”, as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Part of CEN\/TS 14507 either as the General Standard or as the General requirements.<\/p>\n
The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following:<\/p>\n
1.1<\/b> This Part of CEN\/TS 14507 specifies particular requirements for inhalational nitric oxide delivery systems and their modules. It covers devices which can be supplied in combined units, integrated into another medical device, for example a lung ventilator, or as individual devices.<\/p>\n
This Part of CEN\/TS 14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide.<\/p>\n
This Part of CEN\/TS 14507 covers the requirements for inhalational nitric oxide delivery systems intended for medical use, for example, in critical care, anaesthesia, and emergency\/transport environments.<\/p>\n
\nNOTE It is recognized that from time to time innovations and designs will appear that offer advantages and yet are not covered by specific safety-related design or performance aspects of this Part of CEN\/TS 14507; such innovations are not to be discouraged. As the techniques and technologies in these innovations advance, it is essential that the safety objectives of this Part of CEN\/TS 14507 are considered as minimum requirements.<\/p>\n<\/blockquote>\n
The requirements of clause 1.3 of the General Standard apply with the following additions:<\/p>\n
The numbering of clauses and subclauses of this Part of CEN\/TS 14507 corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:<\/p>\n
\u00b4Replacement\u00b4 means that the clause or subclause of the General Standard is replaced completely by the text of this Part of CEN\/TS 14507.<\/p>\n
\u00b4Addition\u00b4 means that the text of this Part of CEN\/TS 14507 is additional to the requirements of the General Standard.<\/p>\n
\u00b4Amendment\u00b4 means that the clause or subclause of the General Standard is amended as indicated by the text of this Part of CEN\/TS 14507.<\/p>\n
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101. Additional annexes are lettered AA, BB, etc. and additional items aa), bb), etc.<\/p>\n
The term \u00b4this Standard\u00b4 is used to make reference to the General Standard and this Part of CEN\/TS 14507 taken together.<\/p>\n
Where there is no corresponding section, clause or subclause in this Part of CEN\/TS 14507, the section, clause or subclause of the General Standard applies without modification.<\/p>\n
Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Part of CEN\/TS 14507.<\/p>\n","protected":false},"excerpt":{"rendered":"
Inhalational nitric oxide systems – Delivery systems<\/b><\/p>\n
\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2003<\/td>\n 30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277054,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-277050","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/277050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/277054"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277050"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277050"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}