ISO 18562-1-2017_ Biocompability evaluation of breathing gas pathways in healca

ISO 2017Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management processvaluation de la biocompatibilit des voies de gaz respiratoires dans les applications de soins de sant Partie 1: valuation et essais au sein dun processus de gestion du risqueINTERNATIONAL STANDARDISO18562-1First edition2017-03Reference numberISO 18562-1:2017(E)ISO 18562-1:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland the requester. Ch. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47 7ISO 18562-1:2017(E)Foreword ivIntroduction v1 Scope .12 Normative references 2u .24 General principles applying to evaluation of 64.1 General .64.2 .74.3 .84.4 Extent of .84.5 evaluation plan .94.6 Selection of tests .104.7 Subsequent evaluation 105 Contamination of breathing gas from 115.1 * Duration of use .115.2 () emissions .135.3 ( ) emissions 135.4 in condensate 136 Adjustment for different groups 136.1 General considerations .13xt .136.3 * Deriving a permitted concentration from a .147 * Deriving allowable limits 147.1 General 147.2 For tv 157.3 For intended for prolonged exposure use (24 h but 24 h but 30 d) if possible, obtain prolonged exposure inhalational exposure limits for that compound from (g/kg stran adult. tvuxr tv is 120 g.Use the described in 6.2 (in (in g/d). This allowed dose-to- , in g/d, of this substance.7.4 For ur if possible, obtain permanent contact inhalational exposure l imits for that compound from (g/kg for (permanent contact) value of 40 g/ds tvuxr tv is 120 g and thereafter 40 g/d. NOTE 2 A of 40 g/d represents the current state-of-the-art measurement threshold for . It represents an increase in the excess cancer of 1 in 2,7 10vas compared to 1 in 10wfor shorter exposures. for (permanent contact) value swu tvuxr tv is 120 g and thereafter 1,5 g/d.Use the described in 6.2 (in (in g/d). This allowed dose-to- , in g/d, of this substance.8 derived above, then the should review the materials and manufacturing . If , then the outweigh the posed to the from this substance being present. 16 ISO 2017 All rights reservedISO 18562-1:2017(E)applicable to critical life-saving without which the will die or for for which there are no alternatives.EXAMPLE The of the are similar to the of other similar NOTE 1 ISO 14971:2007, 6.5 describes When the , the shall disclose the in the .The shall document the results of NOTE 2 Some evaluate this Check compliance by inspection of the plan and .9 Assess the of the A evaluation of a is part of an overall .The potential associated with the the purposes of this document, the arising from the shall associated with those shall be assessed and a evaluation plan developed. shall be The dose that the shall be calculated for each substance of interest.The for each of these substances shall be derived, following the procedure in Clause 7 of this document.If the dose the for that compound, then the complies with this document.If the dose to the of one or more compounds exceeds the , but it is not practicable to alter the materials or manufacture, and the outweigh the , then the complies with this document.NOTE Some assess the evaluation. ISO 2017 All rights reserved 17ISO 18562-1:2017(E)Annex A (informative) Rationale and guidanceA.1 General guidanceThis annex provides rationale for the important requirements of this document and is intended for those who are familiar with the subject of this document but who have not participated in its development. An understanding of the reasons for the main requirements is considered to be essential for its proper The clauses and subclauses in this annex have been so numbered to correspond to the clauses and A.2 Rationale for particular clauses and subclausesSubclause 5.1 Duration of use tv tvur urThese times have been chosen to be consistent with the ISO 10993 series categories A, B and C for duration of use.Subclause 6.3 Deriving a permitted concentration from a Data for minute ventilation in infants and children are found in Reference 9. It has reference data for 12 and 13. These data are summarized in Table A.1. rw uwsrpaediatric and 70 kg for adult . The default breathing volumes are 0,21 m3/d, 2 m3/d, 5 m3/d, and 20 m3 Table A.1 Ventilation data by body size sizeBody weight (BW)kgProposed total ventilation for dosem3/dNeonate 0,21 0,5Infant 3,5 2,0Paediatric 10 5,0Adult s 70 2018 ISO 2017 All rights reservedISO 18562-1:2017(E)Clause 7 Deriving allowable limitsThe choice of a yr uxr exposure), 120 g/d (prolonged exposure) and 1,5 g/d (permanent contact) was discussed at length , a value (g/d) based on the Table A.1 should be derived.The inhalation value for prolonged (24 h to 30 d) exposure to released into the is based on: the 5th percentile of a distribution of noncancer () values derived from inhalation NOAEL (no observed adverse effect level) and LOAEL (lowest observed adverse effect ur suw 14 exposure to the ur y 15(120 g/d).The lower of the two values, 120 g/d, was selected as the inhalation value for prolonged exposure and this value is intended to be protective for both cancer and noncancer effects.Recognizing that exposure limits can be adjusted to permit higher levels of exposure for shorter durations, the prolonged inhalation was adjusted upwards to derive a limited exposure duration uxr C Tn= k)16 n = 0.33 was used to estimate an airborne concentration (C) of a that produces an equivalent toxicological response in 24 h to that seen after inhalation exposure to 120 g/d for 30 d. The three-fold increase in the limited exposure duration compared to the for prolonged exposure is consistent with similar efforts to extrapolate exposure limits from longer to shorter durations. yr vr limit for s using standardized test methods is 2 g/m3. Thus, a proposed limit of 2 g/m3as a concentration is as low as possible to measure. A concentration of 2 g/m3gives a total dose-to- for an adult (who breathes 20 m3 vr limit below 40 g/d were to be proposed, it would be meaningless, as it would not be possible to measure it.It is recognized that these limits can be adjusted in the future as more knowledge becomes known and felt that the proposed limits of 360 g/d (limited exposure duration), 120 g/d (prolonged exposure vr expose to unacceptable . to gases supplied to . The exposure. ISO 2017 All rights reserved 19ISO 18562-1:2017(E)Annex B (informative) Reference to the essential principles as components of according to ISO 16142-16. This document is intended to essential princ