TIU CHUN VIT NAM

TCVN 7394-2:2008
ISO 11607-2:2006
BAO GI TRANG THIT B Y T TIT KHUN - PHN 2: YU CU NH GI XC NHN I
VI QU TRNH TO HNH, NIM KN V LP RP
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,
sealing and assembly processes

Li ni u
TCVN 7394-2:2008 v TCVN 7394-1:2008 thay th TCVN 7394:2004.
TCVN 7394-2:2008 hon ton tng ng vi ISO 11607-2:2006.
TCVN 7394-2: 2008 do Tiu ban k thut tiu chun quc gia TCVN/TC210/SC2 Trang thit b y t
bin son, Tng cc Tiu chun o lng Cht lng ngh, B Khoa hc v Cng ngh cng b.
B tiu chun TCVN 7394 (ISO 11607) Bao gi trang thit b y t tit khun, gm cc tiu chun
sau:
- TCVN 7394-1: 2008 (ISO 11607-1: 2006) Phn 1: Yu cu i vi vt liu, h thng bo v v khun
v h thng bao gi;
- TCVN 7394-2:2008 (ISO 11607-2:2006) Phn 2: Yu cu nh gi xc nhn i vi qu trnh to
hnh, nim kn v lp rp.

Li gii thiu
Trang thit b y t phn phi trong tnh trng v khun cn c thit k, sn xut v bao gi m
bo sao cho chng c v khun khi lu thng trn th trng v duy tr c v khun, n khi h
thng bo v v khun b h hng hoc b m, trong iu kin bo qun v vn chuyn c lp
thnh vn bn. Ngoi ra, trang thit b y t phn phi trong tnh trng v khun cn c sn xut v
tit khun bng mt phng php thch hp v c nh gi xc nhn.
Mt tiu ch c bn nht i vi h thng bo v v khun v h thng bao gi trong trang thit b y t
v khun l m bo duy tr tnh v khun. Nghin cu v nh gi xc nhn qu trnh bao gi ch
yu l m bo t c tnh nguyn vn ca h thng bo v v khun v duy tr cho n khi
ngi s dng m trang thit b y t v khun ra.
Cn c mt k hoch nh gi xc nhn qu trnh c lp thnh vn bn chng t hiu qu
v ti lp ca ton b cc qu trnh tit khun v bao gi. Cng vi qu trnh tit khun, mt vi
thao tc bao gi c th nh hng n tnh nguyn vn ca h thng bo v v khun l vic to
hnh, nim kn, y np hoc h thng ng kn, vic ct v qu trnh ng gi khc. Tiu chun ny
cung cp c cu t chc cc hot ng v yu cu nghin cu v nh gi xc nhn qu trnh
thc hin v lp rp h thng bao gi. TCVN 7394-1 (ISO 11607-1) v TCVN 7394-2 (ISO 11607-2)
c thit k p ng Cc yu cu thit yu ca Hng dn Trang thit b y t Chu u.
Thut ng l mt ro cn quan trng cho s hi ha. Cc thut ng bao gi (package), bao gi cui
cng (final package), gi cui cng (final pack), gi s cp (primary pack) v bao gi s cp
(primary package), tt c c ngha khc nhau trn ton cu, v vic chn mt trong cc thut ng
lm c s hi ha cho tiu chun ny c coi nh mt tr ngi hon tt ti liu ny. Thut
ng h thng bo v v khun (sterile barrier system) c dng m t bao gi ti thiu c
yu cu thc hin nhim v duy nht c yu cu vi bao gi y t: cho php tit khun, ngn cn
vi sinh vt v cho php m bo v khun. Bao gi bo v (Protective packaging) bo v h thng
bo v v khun v cng vi chng to thnh h thng bao gi. H thng bo v v khun to trc
(Preformed sterile barrier systems) s bao gm bt k h thng bo v v khun no kt hp vi mt
phn, chng hn nh ti, ti c u dn hoc ng bao gi bnh vin. Tng quan v h thng bo v
v khun nu trong Ph lc A.
H thng bo v v khun l thit yu m bo an ton cho trang thit b y t tit khun. C
quan c thm quyn nh gi xc nhn trng thi t nhin ch yu ca h thng bo v v khun
bng cch coi chng nh mt ph kin hoc mt b phn ca trang thit b y t. H thng bo v v
khun to trc c bn s dng tit khun bn trong cho phng tin chm sc sc khe c
coi nh l trang thit b y t nhiu ni trn th gii.

BAO GI TRANG THIT B Y T TIT KHUN - PHN 2: YU CU NH GI XC NHN

I VI QU TRNH TO HNH, NIM KN V LP RP
 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes
1. Phm vi p dng
Tiu chun ny quy nh cc yu cu i vi vic nghin cu v nh gi xc nhn qu trnh bao gi
trang thit b y t tit khun. Qu trnh ny bao gm vic to hnh, nim kn v lp rp h thng bo
v v khun to trc, h thng bo v v khun v h thng bao gi.
Tiu chun ny c th p dng cho ngnh cng nghip, cho cc phng tin chm sc sc khe v
bt c ni no trang thit b y t c ng gi v tit khun.
Tiu chun ny khng cp n tt c cc yu cu bao gi trang thit b y t c sn xut v
khun. Yu cu b sung cng c th cn thit i vi s kt hp gia thuc/trang thit b.
2. Ti liu vin dn
Cc ti liu vin dn sau y l cn thit khi p dng tiu chun ny. i vi cc ti liu vin dn ghi
nm cng b th p dng bn c nu. i vi cc ti liu vin dn khng ghi nm cng b th p
dng bn mi nht, bao gm c bn sa i (nu c).
TCVN 7394-1 (ISO 11607-1), Bao gi trang thit b y t tit khun - Phn 1: Yu cu i vi vt
liu, h thng bo v v khun v h thng bao gi.
3. Thut ng v nh ngha
Tiu chun ny s dng cc thut ng v nh ngha sau y:
3.1. Hn s dng (expiry date)
Biu th ngy thng cn s dng c ca sn phm, c th hin t nht l nm v thng.
3.2. Xc nhn cht lng lp t (installation qualification)
IQ
Qu trnh thu thp cc bng chng v lp thnh vn bn chng t thit b c cung cp v lp t
tun theo ng quy nh k thut ca chng.
[ISO/TS 11139:2006]
3.3. Ghi nhn (labelling)
Ni dung c vit, in, dng in t hoc ha gn vo mt trang thit b y t hoc h thng bao
gi ca n; hoc i km vi mt trang thit b y t.
CH THCH Ghi nhn lin quan ti s nhn bit, m t k thut v s dng trang thit b y t nhng
khng bao gm n t hng.
3.4. Xc nhn cht lng vn hnh (operational qualification)
OQ
Qu trnh thu thp bng chng v lp thnh vn bn chng t thit b c lp t v vn hnh trong
phm vi cc gii hn c xc nh trc khi s dng theo ng quy trnh vn hnh chng.
[ISO/TS 11139:2006]
3.5. H thng bao gi (packaging system)
S kt hp ca h thng bo v v khun v bao gi bo v.
[ISO/TS 11139:2006]
3.6. Xc nhn cht lng tnh nng (performance qualification)
PQ
Qu trnh thu thp bng chng v lp thnh vn bn chng t thit b khi lp t v vn hnh theo
ng quy trnh vn hnh, thc hin ph hp theo tiu chun c xc nh trc v do sn
xut sn phm p ng quy nh k thut ca chng.
[ISO/TS 11139:2006]
3.7. H thng bo v v khun to trc (preformed sterile barrier system)
H thng bo v v khun c lp rp mt phn dng cho y vo, ri cui cng c ng
kn hoc dn kn li.
CH THCH Cc ti nh, bao, vt cha c th s dng li h.
[ISO/TS 11139:2006]
3.8. Nghin cu qu trnh (process development)
Thit lp cc gi tr v gii hn danh ngha cho cc thng s ti hn ca qu trnh.
[ISO/TS 11139:2006]
3.9. Sn phm (product)
Kt qu ca mt qu trnh.
[TCVN/ISO 9000 (ISO 9000)]
CH THCH i vi mc ch ca cc tiu chun tit khun, sn phm l vt hu hnh v c th l vt
liu th, dng trung gian, dng thp v sn phm chm sc sc khe.
[ISO/TS 11139:2006]
3.10. Bao gi bo v (protective packaging)
Cu hnh ca vt liu c thit k trnh h hi cho h thng bo v v khun v nhng thnh
phn c cha ng trong n t khi chng c lp rp n khi s dng.
CH THCH Theo ISO/TS 11139:2006.
3.11. lp li (repeatability)
Tnh thng nht cht ch gia cc kt qu o lin tip ca cng mt lng c th ty thuc vo php
o c thc hin trong cc iu kin o nh nhau.
CH THCH 1 Cc iu kin ny c gi l cc iu kin lp li.
CH THCH 2 Cc iu kin lp li c th bao gm nh sau:
- cng quy trnh o;
- cng ngi quan st;
- cng dng c o, s dng trong cc iu kin nh nhau;
- cng v tr;
- nhc li trong mt khong thi gian ngn.
CH THCH 3 lp li c th biu din s lng trong thut ng v c trng cc kt qu phn tn.
CH THCH 4 Theo T vng quc t c bn v Thut ng chung trong o lng, 1993, nh ngha
3.6.
3.12. ti lp (reproducibility)
Tnh thng nht cht ch gia cc kt qu o ca cng mt lng c th ty thuc vo php o c
thc hin trong cc iu kin thay i ca php o.
CH THCH 1 Cng b chnh thc v ti lp phi i km cc yu cu k thut i vi cc iu kin
thay i.
CH THCH 2 Cc iu kin thay i c th bao gm:
- nguyn tc o;
- phng php o;
- ngi quan st;
- dng c o;
- tiu chun tham kho;
- v tr;
- iu kin s dng;
- thi gian.
CH THCH 3 ti lp c th biu din nh lng trong thut ng v c tnh phn tn ca cc kt
qu.
CH THCH 4 Theo T vng quc t c bn v Thut ng chung trong o lng, 1993, nh ngha
3.7.
3.13. Vt cha c th s dng li (reusable container)
H thng bo v v khun dng cng c thit k s dng li.
3.14. H thng bo v v khun (sterile barrier system)
Bao gi ti thiu ngn cn vi khun xm nhp v cho php gi v khun cho sn phm n khi s
dng.
[ISO/TS 11139:2006]
3.15. Bao gi ng dn cht lng v khun (sterile fluid-path packaging)
H thng np cng bo v v/hoc bao gi c thit k m bo v khun ca phn trang
thit b y t tip xc vi cht lng.
3.16. nh gi xc nhn (validation)
<Qu trnh> quy trnh c ghi thnh vn bn v vic thu nhn, lp h s v trnh by kt qu cn
thit chng minh rng qu trnh sn xut ra sn phm ph hp vi cc yu cu nh trc.
CH THCH Theo ISO/TS 11139:2006.
4. Yu cu chung
4.1. H thng cht lng
4.1.1. Cc hot ng c m t trong tiu chun ny phi c thc hin trong h thng cht lng
chnh thc.
CH THCH TCVN/ISO 9001 (ISO 9001) v TCVN/ISO 13485 (ISO 13485) nu ra yu cu i vi h
thng cht lng ph hp. Cc yu cu b sung c th c quy nh bi cc quc gia hoc khu vc.
4.1.2. Khng cn c chng nhn ca bn th ba i vi h thng cht lng p ng yu cu ca
tiu chun ny.
4.1.3. Phng tin chm sc sc khe c th s dng h thng cht lng theo yu cu ca quc
gia hoc khu vc.
4.2. Ly mu
K hoch ly mu dng la chn v th nghim h thng bao gi phi c th p dng c cho
h thng bao gi c nh gi. K hoch ly mu phi da trn c s c gi tr thng k hp l.
CH THCH V d v k hoch ly mu ph hp c a ra trong TCVN 7790-1 (ISO 2859-1) hoc
TCVN 3649 (ISO 186). K hoch ly mu b sung c th c quy nh bi quc gia hoc khu vc.
4.3. Phng php th
4.3.1. Tt c cc phng php th s dng ch ra s ph hp vi tiu chun ny phi c
nh gi xc nhn v lp thnh vn bn.
CH THCH Ph lc B trong TCVN 7394-1:2008 (ISO 11607-1:2006) bao gm danh mc cc phng
php th ph hp.
4.3.2. Vic nh gi xc nhn phng php th phi chng minh tnh ph hp ca phng php khi
c s dng. Phi bao gm cc yu t sau:
- thit lp l do i vi vic la chn php th thch hp cho h thng bao gi;
- thit lp tiu ch chp nhn;
CH THCH t/khng t l mt kiu tiu ch chp nhn.
- xc nh lp li ca phng php th;
- xc nh ti lp ca phng php th; v
- thit lp phng php th nhy i vi cc php th tnh nguyn vn.
4.3.3. Tr nhng iu quy nh trong phng php th, cc mu th phi c bo qun nhit
(23 1)oC v m tng i (50 2) % trong thi gian ti thiu l 24 h.
4.4. H thng ti liu
4.4.1. Chng minh s ph hp vi cc yu cu ca tiu chun ny phi c lp thnh vn bn.
4.4.2. Tt c nhng ti liu lm bng chng phi c lu gi trong khong thi gian quy nh.
Khong thi gian lu gi phi c xem xt cc yu t chng hn nh cc yu cu quy nh, hn s
dng v kh nng truy tm ngun gc ca trang thit b y t hoc h thng bo v v khun.
4.4.3. Ti liu ph hp vi cc yu cu c th bao gm cc d liu v tnh nng, yu cu k thut, kt
qu th t cc phng php th c nh gi xc nhn, cc th tc v kt qu t IQ, OQ, PQ,
nhng khng ch hn ch trong cc yu cu ny.
4.4.4. Cc bn ghi in t, ch k in t v ch k bng tay thc hin ghi in t cho vic
nh gi xc nhn, kim sot qu trnh hoc cc qu trnh ra quyt nh cht lng khc phi ng tin
cy.
5. nh gi xc nhn qu trnh bao gi
5.1. Quy nh chung
5.1.1. Qu trnh sn xut h thng bo v v khun to trc v h thng bo v v khun phi c
nh gi xc nhn.
Cc v d v cc qu trnh ny bao gm, nhng khng hn ch i vi:
- to ch phng cng hoc mm;
- to hnh v dn kn ti, ng hoc bao cha;
- qu trnh to hnh/lm y/dn kn t ng;
- lp rp v ng gi b dng c y t;
- lp rp sn phm ng dn cht lng v khun;
- bt kn khay/np;
- lm y v ng cc vt cha c th s dng li;
- gp np v bao bc bng tm ph v khun.
5.1.2. Qu trnh nh gi xc nhn bao gm xc nhn cht lng lp t, vn hnh v thc hin
cp ti thiu theo trt t ny.
5.1.3. Nghin cu qu trnh, trong khi khng phi l phn chnh ca nh gi xc nhn qu trnh, cn
c coi nh mt phn khng th thiu ca vic to hnh v nim kn (xem Ph lc A).
5.1.4. nh gi xc nhn sn phm hin c c th da vo d liu t xc nhn cht lng lp t v
vn hnh trc . D liu c th c s dng xc nh dung sai cho cc thng s ti hn.
5.1.5. Khi qu trnh sn xut h thng bo v v khun to trc v h thng bo v v khun tng
t c nh gi xc nhn, l do thit lp s ging nhau v nhn bit trng hp c cu hnh
khng thch hp nht phi c lp thnh vn bn. Ti thiu, cu hnh khng thch hp nht phi
c nh gi xc nhn xc nh s ph hp vi tiu chun ny.
CH THCH V d, s ging nhau c th c thit lp bng cc kch c khc nhau ca h thng bo
v v khun to trc.
5.2. Xc nhn cht lng lp t (IQ)
5.2.1. Xc nhn cht lng lp t phi c thc hin.
Mt vi xc nhn cht lng lp t phi c xem xt l:
- c trng thit k ca thit b;
- iu kin lp t, v d nh h thng dy in, s tin ch, chc nng, v.v...
- c trng an ton;
- vn hnh thit b theo thng s thit k c cng b;
- nh cung cp ti liu, my in, bn v v sch ch dn thc hnh;
- danh mc cc b phn d phng;
- s nh gi xc nhn phn mm;
- iu kin mi trng, v d nh tnh trng sch s, nhit , m;
- h s o to ngi vn hnh;
- hng dn hoc quy trnh vn hnh.
5.2.2. Phi xc nh cc thng s ti hn ca qu trnh.
5.2.3. Phi kim tra v gim st cc thng s ti hn ca qu trnh.
5.2.4. Chung bo ng, h thng cnh bo hoc dng my phi c kim chng trong trng hp
cc thng s ti hn ca qu trnh vt qu gii hn xc nh trc.
5.2.5. Cc dng c o, b phn cm bin, hin th, b kim sot v.v qu trnh ti hn phi c cp
chng ch khi hiu chun v phi vit k hoch hiu chun. Vic hiu chun cn c thc hin trc
v sau khi xc nhn cht lng tnh nng.
5.2.6. Phi vit k hoch bo dng phng nga v v sinh.
5.2.7. S p dng h thng phn mm, nh b kim tra nguyn l lp trnh, la chn d liu v h
thng kim tra phi c nh gi xc nhn m bo rng chng thc hin chc nng nh d
nh. Th nghim chc nng phi c thc hin xc minh chc nng ca phn mm v phn
cng l ng, c bit l giao din. H thng phi c kim tra (v d bng vic nhp d liu vo
chnh xc hoc khng chnh xc, bng vic m phng mt ngun in) nhn ra d liu v bn ghi
c gi tr, tin cy, ging ht nhau, chnh xc v c th truy nguyn ngun gc.
5.3. Xc nhn cht lng vn hnh (QC)
5.3.1. Thng s ca qu trnh phi c kim chng m bo rng chng s a ra h thng bo
v v khun to trc v h thng bo v v khun p ng c tt c cc yu cu c xc
nh di cc iu kin bit trc ca vic sn xut.
5.3.2. H thng bo v v khun to trc v h thng bo v v khun phi c sn xut c hai
gii hn thng s trn v di, v phi th hin cc ch tiu p ng cc yu cu c xc nh
trc. Ch tiu cht lng sau y phi c xem xt:
a) i vi to hnh/lp ghp:
- h thng bo v v khun c to hnh/lp t hon chnh;
- sn phm gn vo h thng bo v v khun;
- cc kch thc cn thit c p ng.
b) i vi nim kn:
- du nim kn cn nguyn vn i vi rng nim kn c quy nh;
- rnh hoc nim kn h;
- thng hoc rch;
- tch lp hoc phn ly vt liu.
CH THCH Xem EN 868-5:1999, 4.3.2 i vi v d v quy nh rng nim kn.
c) i vi h thng ng kn khc:
- ng kn lin tc;
- thng v rch;
- tch lp hoc phn ly vt liu.
5.4. Xc nhn cht lng tnh nng (PQ)
5.4.1. Xc nhn cht lng tnh nng phi chng minh c rng qu trnh s ph hp vi sn xut
h thng bo v v khun to trc v h thng bo v v khun c chp nhn, di cc iu kin
vn hnh quy nh.
5.4.2. Xc nhn cht lng tnh nng phi bao gm:
- sn phm thc t hoc c m phng;
- thng s ca qu trnh thit lp trong xc nhn cht lng vn hnh;
- yu cu kim tra sn phm/bao gi;
- s m bo ca qu trnh kim tra v kh nng thc hin;
- ti lp v lp li ca qu trnh.
5.4.3. Kim chng i vi qu trnh phi bao gm nhng iu kin c cho rng s gp phi trong
khi sn xut.
CH THCH S kim chng ny c th bao gm, nhng khng hn ch i vi vic b tr my, quy
trnh thay i; quy trnh khi ng v khi ng li; li v dao ng ngun, v di chuyn nhiu, nu c.
5.4.4. Kim chng i vi qu trnh phi bao gm t nht ba ln chy th sn xut c ly mu y
chng minh tnh thay i trong khi chy th v ti lp gia cc ln chy th khc nhau. Khong
thi gian ca mt ln chy th sn xut cn tnh ton trong lng c th thay i ca qu trnh.
CH THCH S thay i ny bao gm, nhng khng hn ch i vi trng thi cn bng ca my, s
gin on v thay i di chuyn, khi ng v dng thng thng, v s khc nhau gia cc l vt
liu.
5.4.5. Quy trnh c lp thnh vn bn v cc yu cu k thut i vi to hnh, nim kn v vn
hnh lp t phi c thit lp v kt hp vi xc nhn cht lng tnh nng.
5.4.6. Cc thay i quy trnh thit yu phi c kim sot v ghi li.
5.4.7. Qu trnh phi c kim sot v c kh nng ph hp vi vic sn xut theo yu cu c
xc nh trc.
5.5. Chp nhn chnh thc vic nh gi xc nhn qu trnh
5.5.1. Xem xt v chp nhn chnh thc s nh gi xc nhn qu trnh phi c thc hin v lp
thnh vn bn nh mt bc cui cng trong chng trnh nh gi xc nhn.
5.5.2. Nhng ti liu lm bng chng phi c tm tt v vin dn tt c cc th tc v kt qu, v
cng b cc kt lun v tnh trng nh gi xc nhn ca qu trnh.
5.6. Kim tra v theo di qu trnh
5.6.1. Quy trnh phi c thit lp m bo rng qu trnh bao gi c kim sot v trong phm
vi cc thng s c thit lp trong khi vn hnh thng quy.
5.6.2. Thng s ti hn ca qu trnh phi c theo di thng quy v lp thnh vn bn.
5.7. Thay i v nh gi xc nhn li qu trnh
5.7.1. Nhng ti liu lin quan n qu trnh bao gi v nim kn phi c kim sot bng quy trnh
kim sot s thay i i vi vic chng minh bng ti liu, xc minh v thay i y quyn.
5.7.2. Cc qu trnh phi c nh gi xc nhn li nu cc thay i c thc hin i vi thit b,
sn phm, vt liu bao gi hoc qu trnh bao gi, chng lm tn hi n s nh gi xc nhn ban
u v nh hng n s v khun, an ton hoc hiu qu ca trang thit b y t v khun.
CH THCH Sau y l danh mc nhng thay i c th nh hng n tnh trng ca mt qu trnh
c nh gi xc nhn:
- s thay i nguyn liu th s tc ng n thng s ca qu trnh;
- b phn mi ca thit b c lp t;
- s dch chuyn qu trnh v/hoc thit b t mt phng tin hoc v tr n mt ch khc;
- thay i qu trnh tit khun;
- xu hng tiu cc trong cc ch th v cht lng hoc kim sot qu trnh.
5.7.3. S cn thit i vi vic nh gi xc nhn phi c nh gi v lp thnh vn bn. Nu hon
cnh khng yu cu m tt c cc kha cnh ca s nh gi ban u c lp li, th s nh gi
xc nhn li ny khng c phm vi rng nh nh gi ban u.
5.7.4. S nh gi xc nhn li nh k hoc cc xem xt phi c xem xt v nhiu thay i th yu
c th tch t nh hng n tnh trng nh gi xc nhn ca qu trnh.
6. Qu trnh lp rp h thng bao gi
6.1. H thng bo v v khun phi c lp rp di iu kin mi trng thch hp gim thiu
ri ro do cht gy nhim i vi trang thit b y t.
6.2. Qu trnh lp rp h thng bao gi phi tin hnh sau khi qu trnh sn xut v nhn c kim
sot ngn nga gn nhn sai.
CH THCH Hng dn b sung c th tm thy trong DIN 58953-7 v DIN 58953-8.
6.3. H thng bao gi phi c lp rp v lm y theo hng dn da trn qu trnh c nh
gi xc nhn m bo s tit khun trong qu trnh tit khun c xc nh. Hng dn ny
phi bao gm cu hnh cc vt cha bn trong v t chc vic lng vo trong, tng trng lng, giy
gi bn trong v vt liu thm ht.
7. S dng h thng bo v v khun c th s dng li
Hng dn v hn ch s dng nh quy nh trong 5.1.10 v 5.1.11 ca TCVN 7394-2:2008 (ISO
11607-1:2006) phi c b sung tip theo vo cc yu cu lit k trong iu 6 (v d: lp rp, tho
ra, bo dng, sa cha, bo qun).
CH THCH i vi hng dn b sung v vt cha c th s dng li, xem EN 868-8, DIN 58953-9,
v AAMI/ANSI ST33. i vi hng dn b sung v v i c th s dng li, xem EN 13795-1 v
ANSI/AAMI ST65.
8. Bao gi ng dn cht lng v khun
8.1. Lp rp cc b phn ng dn cht lng v khun v ng kn phi p ng cc yu cu ca
iu 5 v 6.
8.2. Cc trang thit b y t ghi nhn ng dn cht lng v khun phi duy tr tnh v khun ca
ng dn cht lng bng cu trc ca trang thit b kt hp vi s ng kn ca chng.
CH THCH 1 Cc yu cu i vi cc ch tiu ngn vi sinh vt v tnh nguyn vn ca h thng bo
v v khun c trong TCVN 7394-1 (ISO 11607-1). Cc yu cu ph hp vi bn thn trang thit b.
CH THCH 2 i vi mc ch bin dch cc yu cu ca tiu chun ny, trang thit b v s ng
kn ca chng to thnh h thng bo v v khun.

Ph lc A
(tham kho)
 Nghin cu qu trnh
Nghin cu qu trnh, khng phi l ni dung chnh thc ca vic nh gi xc nhn qu trnh, cn
c coi nh mt phn y ca vic to hnh v nim kn. Nghin cu qu trnh hoc thit k qu
trnh phi bao gm nh gi nhn bit v phn tch cc thng s ti hn, kt hp vi di vn hnh,
ci t v dung sai ca chng.
nh gi qu trnh c tin hnh thit lp gii hn cao hn v thp hn cn thit v ph hp ca
qu trnh, cng nh cc iu kin vn hnh chun mc c thc hin. Cc gii hn qu trnh ny
phi rt ra t cc iu kin khng thch hp hoc bt li. Mt phng php k thut c th lm
lch sc bn nim kn vi cc kt qu ca mu quan st tin hnh song song c th gip cho la
chn mt ca s qu trnh ti u.
Kiu khng thch hp tim n v mc hot ng c nh hng ln nht ln qu trnh cn c
nhn bit v c ch (kiu khng thch hp v phn tch cc tc ng, nguyn nhn v phn tch
hiu qu).
Nhng k thut c gi tr thng k nh l nhng th nghim sng lc v nhng th nghim c thit
k mt cch thng k ti u ha qu trnh phi c s dng.
Cc thng s ti hn ca qu trnh c nh gi c th bao gm, nhng khng hn ch i vi:
- nhit ;
- p sut/ chn khng, bao gm tc thay i;
- thi gian ngng (ng k tc );
- mc nng lng/tn s (tn s radio/siu m);
- gii hn mmen i vi h thng ng kn np.
Cc thng s thit yu c la chn phi c chn sao cho chng s to ra mt qu trnh c
kim sot v c kh nng cung cp h thng bo v v khun v h thng bao gi p ng cc yu
cu k thut thit k xc nh trc.

Th mc ti liu tham kho

[1] TCVN 3649:2007 (ISO 186:2002) Giy v cctng - Ly mu xc nh cht lng trung bnh.
[2] TCVN 7790-1 (ISO 2859-1) Quy trnh ly mu kim tra nh tnh - Phn 1: Chng trnh ly mu
c xc nh theo gii hn cht lng chp nhn (AQL) kim tra tng l.
[3] TCVN/ISO 9001:2000 (ISO 9001:2000) H thng qun l cht lng - Cc yu cu.
[4] ISO 11139:2006 Sterilization of heath care products - Vocabulary (Tit khun sn phm chm sc
sc khe - Yu cu xc nhn v kim sot thng quy - T vng).
[5] TCVN/ISO 13485:2004 (ISO 13485:2003) Dng c y t - H thng qun l cht lng - Yu cu
i vi cc mc ch ch nh.
[6] TCVN/ISO 9000 (ISO 9000) H thng qun l cht lng - Nguyn tc c bn v t vng.
[7] EN 868-5:1999 Packaging material and systems for medical device which are to be sterilized - Part
5: Heat and self-sealable pouches and reel of paper and plastic film construction) - Requirements and
test methods (Vt liu v h thng bao gi trang thit b y t tit khun - Phn 5: Ti nh nim kn
bng nhit v t nim kn v cu trc ca ng cun v mng cht do - Yu cu v phng php
th).
[8] EN 868-6:1999 Packaging material and systems for medical device which are to be sterilized - Part
6: Paper for the manufacture of packs for medical use for sterilization by ethylen oxit or irradiation -
Requirements and test methods (Vt liu v h thng bao gi trang thit b y t tit khun - Phn 6:
Giy sn xut bao gi s dng y t cho tit khun bng etylen oxit v bc x - Yu cu v phng
php th).
[9] EN 868-8:1999 Packaging material and systems for medical device which are to be sterilized - Part
8: Re-usable sterilization containers for steam sterilization conforming to EN 285 - Requirements and
test methods (Vt liu v h thng bao gi trang thit b y t tit khun - Phn 8: Vt cha tit
khun dng li tit khun bng tia nng ph hp vi EN 285 - Yu cu v phng php th).
[10] EN 13795-1:2002, Surgical drapes, gowns and clean air suits, used as medical devices, for
patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and
products (Rm, o chong phu thut v b lm sch khng kh, s dng nh trang thit b y t i
vi bnh nhn, nhn vin y t v thit b - Phn 1: Yu cu chung i vi sn xut, quy trnh x l v
sn phm).
[11] AAMI/ANSI ST33:1996, Guidelines for the selection and use of reusable rigid container systems
for ethylene oxide sterilization and steam sterilization in health care facilities (Hng dn i vi vic
la chn v s dng h thng cc vt cha cng c th s dng li i vi tit khun bng etylen oxit
v tit khun bng hi nc trong phng tin chm sc sc khe)
[12] ANSI/AAMI ST65:2000, Processing of reusable surgical textiles for use in health care facilities
(Qu trnh dt si phu thut c th s dng li i vi s dng trong phng tin chm sc sc
khe)
[13] DIN 58953-7:2003, Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven
wrapping material, paper bags and heat and self-sealable pouches and reels (Tit khun - Cung cp
tit khun - Phn 7: S dng giy, vt liu bao gi khng dt, ti giy v ti nh c kh nng nim kn
bng nhit v t nim kn v cc ng.
[14] DIN 58953-8:2003, Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices (Tit
khun - Cung cp tit khun - Phn 8: Cung ng trang thit b y t v khun).
[15] DIN 58953-9:2000, Sterilization - Sterile supply - Part 9: Handling of sterilization containers (Tit
khun - Cung cp tit khun - Phn 9: ng gi vt cha tit khun).
[16] GHTF Study Group 3, Process validation guidance for medical device manufacturers (Hng dn
quy trnh nh gi xc nhn i vi sn xut trang thit b y t)
[17] International Vocabulary of Basic and General Terms in Metrology (T vng quc t c bn v
thut ng chung v o lng): 1993, BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML.

MC LC
Li ni u
Li gii thiu
1. Phm vi p dng
2. Ti liu vin dn
3. Thut ng v nh ngha
4. Yu cu chung
5. nh gi xc nhn qu trnh bao gi
6. Qu trnh lp rp h thng bao gi
7. S dng h thng bo v v khun c th s dng li
8. Bao gi ng dn cht lng v khun
Ph lc A (tham kho) Nghin cu qu trnh
Th mc ti liu tham kho