KS P ISO 16021-2011 Urine-absorbing aids-Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers《尿吸收辅助器具 从使用者和护.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 16021 KS P ISO 16021:2011 2011 12 13 http:/www.kats.go.krKS P ISO 16021:2011 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2011 12 13 2011-0564 ： ： ( 02-509-7278) (http:/www.kats.go.kr). 10 5 , . KS P ISO 16021:2011 i ii iii 1 1 2 .1 3 .2 3.1 .2 3.2

2、 2 3.3 2 3.4 3 3.5 3 3.6 .3 4 4 4.1 4 4.2 4 4.3 .4 4.4 .5 4.5 .5 5 5 5.1 5 5.2 .6 6 .6 6.1 6 6.2 .6 6.3 7 6.4 .7 6.5 7 7 .7 11 KS P ISO 16021:2011 ii . . . , . , , . . . Q34-019: Mthode dessai au porter pour les articles dhygine infantile, fminine et de lincontinence (articles usage unique) Continen

3、ce Products Evaluation Network at University College . . . . ISO 9949 1:1993, Urine absorbing aids Vocabulary Part 1： Conditions of urinary incontinence ISO 9949 2:1993, Urine absorbing aids Vocabulary Part 2： Products ISO 9949 3:1993, Urine absorbing aids Vocabulary Part 3： Identification of produc

4、t types ISO 11948 1:1996, Urine-absorbing aids Part 1： Whole-product testing ISO 11948 2:1998, Urine-absorbing aids Part 2： Determination of short-time liquid release (leakage) under conditions of light incontinence and low pressure KS P ISO 15621, KS P ISO 16021:2011 iii 2000 1 ISO 16021, Urine-abs

5、orbing aids Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers . KS P ISO 16021:2011 Urine-absorbing aids Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregi

6、vers 1 . , . (leakage performance) . . 2 . 2.1 (caregiver) / . 2.2 (ethics committee) . 2.3 (evaluation center coordinator) KS P ISO 16021:2011 2 2.4 (principal investigator) 2.5 (product) ISO 9949 2 ISO 9949 3 . 2.6 (product line) / . 2.7 (user) 3 3.1 / . , . . , , . . (7. ). . 3.2 (2.5) (2.6) , .

7、3.3 . KS P ISO 16021:2011 3 . 1 . . . 2 . . , , , . . 3 ( ) . 3.4 . . , , . 3.5 . / . , / , . 1 2 . 3.6 , . . , (ward) . ( ) , . KS P ISO 16021:2011 4 . 4 4.1 / . ( 1 ) ( 2 ) ( 3 ) ( 4 ) ( 5 ) ( 6 ) 4.2 . , , , , , , . 4.3 4.3.1 . / . 1 KS P ISO 15621 . 2 1 . / . . . ( , , ) ( , ) . ( , ) . . , . KS

8、 P ISO 16021:2011 5 . , , . 4.3.2 . , . . . . . 1 “ (leakage)” , . 2 5 6 . 4.4 . , , , . 4.5 (2.2) . . ( ) ( / ) 1 2 6 . 2 . 5 5.1 , . / . / . KS P ISO 16021:2011 6 5.2 (2.4) . , , (2.3) . . / . . , . . , . 4.5 . / / , (4.5 5 ). . . 6 6.1 ( ) (4.2 ). 6.2 6.2.1 / (4.3.1 1 ). / ( , ), . 6.2.2 (leakage

9、), / , / . . , (4.3.2 ). . , ( 10 ) . KS P ISO 16021:2011 7 . 6.3 (4.5 6 ). 6.4 / . 6.5 , , , , (4.5 2 5 ). 7 . a) b) (4.4 ) c) / (3.2 3.3 ) d) (3.2 ) e) . . (4. ) / (3.5 ) / (3.2 ) f) (3.6 ) (3.3 ) (3.6 ) g) (4.2 ) h) (3.3 3.4 ) i) (3.3 3.4 ) j) (3.3 ) k) (3.3 ) l) / (3.3 ) m) (4.3 ) n) (4.5 6 ) KS

10、 P ISO 16021:2011 8 1 / ? / ? ( ) ? ? ( ) ? ( )? ? ? ? ? ? ( ) ? ( )? ? ? ( ) ? 2 ： . ： ( ) KS P ISO 16021:2011 9 3 , ( ) , 4 / , , , ( ) ( ) / / ( 4 ) 5 ( ) ( ) , , KS P ISO 16021:2011 10 6 , / KS P ISO 16021:2011 11 1 BAINTON, D., BLANNIN, J.B. and SHEPHARD, A.M. (1982), “Pads and pants for urinar

11、y incontinence”, British Medical Journal, 285, pp. 419-420. 2 BEBER, C.R. (1980), “Incontinent”, American Journal of Nursing, March, pp. 483-484. 3 BOULTON, S.W. and KAZEMI, M.J. (1984), “Evaluating disposable briefs”, American Journal of Nursing, Nov, pp. 1412 and 1439. 4 CLANCY, B. and MALONE-LEE,

12、 J.G. (1991), “Reducing the leakage of body-worn incontinence pads”, Journal of Advanced Nursing, 16, pp. 187-193. 5 COTTENDEN, A.M. and LEDGER, D.J. (1993), “Predicting the leakage performance of bodyworn disposable incontinence pads using laboratory tests”, Journal Biomed. Eng., May, Vol 15, pp. 2

13、12-220. 6 COTTENDEN, A.M., DEAN, G.E. and BROOKS, R.J. (1997), “Predicting the leakage performance of small disposable incontinence pads using laboratory tests”, Med. Eng. Phys., 19 (6), pp. 556-571. 7 DAWSON, B. and WILKINSON, E. (1988), “Ward based comparison of two continence care products”, Care

14、-Science and Practice, 6(4), pp. 105-106. 8 FADER, M.J., BARNES, K.E., COTTENDEN, A.M. and MALONE-LEE, J.G. (1986), “Incontinence garments” results of a DHSS study, Health Equipment Information, p. 159. 9 JOURNET, C. (1981), “DHSS aids assessment programme: Incontinence aids for handicapped children”, HMSO. 10 KELLY, L.S. (1982), “Incontinence: cost effective management in a psychogeriatric ward”, British Journal of Geriatric Nursing, Sep/Oct, pp. 9-10. 11 MACKIN, B. and WEBB, T. (1990), “Evaluating bodyworn continence pads”, Nurs