BOYTE .

CONG HOA xA .
HOI CHU NGHiA VIET NAM .

5
DQe l~p - Tl! do - H~nh phuc

4:4
1:4
2
s6: 05 12022/TT-BYT Ha N(Ji, ngay 01 thang 8 ndm 2022

22
/20
/08
01
THONGTU
c_
sa sa
uo
Quy djnh chi ti~t thi hanh mQt di~u ella Nghi djnh 98/20211ND-CP
Ph

ngay 08 thang 11 nam 2021 ella Chinh phll v~ quan ly trang thi~t b] Yt~
nh
Bi
T
SY

Can ctr Nghi dinh s6 75/2017/ND-CP ngay 20 thang 6 ndm 2017 cua
hu
nt

Chinh phu quy dinh chuc nang, nhiem v?t, quyen han va CO' cdu t6 chtrc cua B(J Y ti;
t_Va
_v

Can cu Nght dinh s6 98/2021/ND-CP ngay 08 thang 11 ndm 2021 cua

c
uo

Chinh phu v~ quan If trang thiit hi y d;

ph
inh

hi va d;
t_b

Thea d~ nghi cua V?ttruong V?tTrang thie: Cong trinh y

sy

B(J truong B(J Y d ban hanh Thong tu quy dinh chi tiit thi hanh mot s6 di~u
cua Nght dinh s6 98/2021/ND-CP ngay 08 thang 11 nam 2021 cua Chinh phu v~
quan If trang thiit bi y d.
Di~u 1. Pham vi di~u chinh
1. Thong tir nay quy dinh chi tiSt thi hanh mot s6 diSu cua Nghi dinh s6
98/20211ND-CP ngay 08 thang 11 nam 2021 cua Chinh phu vS quan ly trang thiSt
bi y tS (sau day viSt t~t la Nghi dinh s6 98/20211ND-CP) g6m:
a) Phan lol;ti trang thiSt bi y tS quy dinh tl;tikhoan 5 DiSu 5 Nghi dinh s6
98/2021/ND-CP;
b) B6 sung danh m\lc trang thiSt bi y tS ch~n doan in vitro khong phai th\Ic
hi~n danh gia ch~t lugng boi co quan co th~m quySn cua Vi~t Nam quy dinh
tl;tidiem d khoan 3 DiSu 30 Nghi dinh s6 98/2021/ND-CP;
c) Danh m\lc trang thiSt bi y tS thu9C lol;tiB, C, D dugc mua, ban nhu cac
hang hoa thong thuang quy dinh tl;ti khoan 1 DiSu 42 Nghi dinh s6
98/2021/ND-CP;
d) Danh m\lc trang thiSt bi y tS phai dugc kiSm dinh vS an toan va tinh
nang ky thu?t quy dinh tl;tikhoan 10 DiSu 70 Nghi dinh s6 98/20211ND-CP;
d) Danh m\lc trang thiStbi y tS c~p gi~y phep nh?p kh:1u quy dinh tl;tiDiSm
d khoan 2 DiSu 76 Nghi dinh s6 98/2021/ND-CP.
2. Cong b6 hSt hi~u l\Ic m9t s6 van ban vS quan ly trang thiSt bi y tS.
 2

Di~u 2. Quy djnh vi~c phfin Io~i trang thi~t b] Y t~

:45
1. Trang thiSt bi y tS duoc phan loai thea mot hoac mot nhorn dS xac dinh

:44
21
rmrc dQ rui ro va c~p so hru hanh,

22
/20
2. Viec phan loai mot hoac mot nhom trang thiet bi y tS phai dua tren co sa

/08
01
quy t~c phan loai v~ mire dQ rui ro A, B, C, D (quy dinh cu thS tai Phu luc I ban
c_
uo
hanh kern thea Thong tu nay).
Ph
inh

3. M~u ban kSt qua phan loai trang thiSt bj y tS diroc thirc hien thea PhV luc II
TB

cua Thong tir nay.

SY
hu

Di~u 3. BB sung danh muc trang thi~t b] y t~ ch~n doan in vitro khdng
nt
Va

phai thuc hi~n danh gia ch~t IU'Q'ngbOi CO' quan co th~m quyen cua Vi~t Nam
vt_

quy djnh tai di~m d khoan 3 Di~u 30 Nghi djnh sB 98/2021IND-CP

c_
uo
ph

1. Btl duoc cap gi~y chUng nh?n luu hanh tv do (Certificate of Free Sale)
inh
t_b

cua mQt trong cac nuac, t6 chuc sau:

sy

a) Cvc Quan Iy Thvc ph~m va DuQ'cph~m Hoa Ky (FDA) - My;

b) Cvc Quan Iy hang hoa tri li~u (TGA) - Dc;
c) Co quan Quan Iy y tS Canada (Health Canada);
d) BQ Y tS, Lao dQng va Phuc IQ'iNh?t Ban (MHL W);
d) Co quan DuQ'cph~m va ThiSt bi y tS Nh?t Ban (PMDA);
e) Cvc Quan Iy san ph~m y tS qu6c gia c~p Trung uang Trung Qu6c (National
Medical Products Administration - NMP A);
g) BQ An toan Thvc ph~m va DuQ'Cph~m Han Qu6c (Ministry of Food &
Drug Safety - MFDS);
h) Cac nuac thuQc thanh vien EU c~p thea quy chS 20171746 ban hanh ngay
05 thang 4 nam 2017 cua HQi d6ng va Nghi vi~n Chau Au v~ trang thiSt bi y tS
ch~n doan in vitro (Regulation (EU) 20171746 of the European Parliament and
of the Council of 5 April 2017 on in vitro diagnostic medical devices).
2. Btl duQ'c c~p s6 luu hanh ho?c Gi~y chtmg nh?n dang ky luu hanh, gi~y
phep nh?p kh~u thea hinh thuc thuong m?i t?i Vi~t Nam, tru cac truang hQ'P
dtl bi thu h6i.
3. Khong phai la thu6c thi'r, ch~t hi~u chu~n, V?t li~u kiSm soat in vitro.
Di~u 4. Danh m\lc trang thi~t bi Y t~ thuQc Io~i B, C, D dtl'Q'cmua, ban
nhtl' cac hang hoa thong thU'irng theo quy dinh t~i khoan 1 Di~u 42 Nghi
dinh sB 98/20211ND-CP
1. May do huySt ap ca nhan.
 3

2. May do nong dQbao hoa oxy trong mau (Sp02) loai dung pin kep ngon tay.

:45
3. May hut mfii tre em.

4
1:4
kS dien tir, nhiet kS hong ngoai,

22
4. Nhiet

02
8/2
5. Cac trang thiSt bi y tS diroc su dung dS do duong huyet ca nhan: may do dirong

1/0
_0
huyet, but l~y mau, que thir, kim l~y mau, dung dich chuan, dung dich clnrng.
Ph
oc
u
6. May xong khi dung.
inh
TB

7. Bang, gac y tS ca nhan.

SY

8. Niroc m~t nhan tao duoc phan loai la trang thiSt bi y tS.
hu
nt
Va

9. Bao cao suo

vt_
c_

10. Mang phim tranh thai (khong chua thuoc).

uo
ph
inh

11. Dung dich boi tron am dao duoc phan loai la trang thiSt bi y tS.
t_b
sy

12. Tui chuom nang, lanh sir dung dien,

13. Trang thiet bi y tS chfin doan in vitro tu xet nghiem thuoc loai B.
14. Trang thiet bi y tS chan doan in vitro tu xet nghiem HIV, SARS-Co V-2.

Di~u 5. Danh muc trang thi~t bi Y t~ phai dU'Q'cki~m dinh v~ an toan va

tinh nang ky thu~t theo quy dinh t~i khoan 10 Di~u 70 Nghi dinh sA
98/2021IND-CP
1. May th6.
2. May gay me kern th6.
3. Dao me, di~n.
4. L6ng ~p tre sa sinh.
5. May pha rung tim.
6. May th~n nhan t~o.

Di~u 6. Danh m1}.ctrang thi~t bi Y t~ c~p gi~y phep nh~p khiu d~ th\fc
hi~n quy dinh t~i di~m d khoan 2 Di~u 76 Nghi dinh sA 98/20211ND-CP
1. Cac thiSt bi chfin doan hinh anh dung tia X.
2. H~ th6ng cQng huang tu.
3. May sieu am chfin doan.
4. H~ th6ng nQi soi chfuI doan.
5. H~ th6ng Cyclotron.
 4

6. Thi@t bi chan doan bang d6ng vi phong X(;1(H~ thong PET, PET/CT,

:45
SPECT, SPECT/CT, thiet bi do d9 t~p trung i6t 1130, 1131).

4
1:4
7. May do khuc X(;1,giac mac tir dong,

22
02
8. May do dien sinh ly (May dien nao, May dien tim, May dien co),

8/2
1/0
9. May do dien vong mac,
_0
oc
10. May do do loang xirong,
u
Ph

11. May chup c~t lap day m~t; May chup huynh quang day mat,
inh
TB

12. May do nhip tim thai bang sieu am.

SY

13. May do/pharr tich chirc nang ho h~p.

hu
nt

14. May phan tich sinh hoa; May phan tich di~n giai, khi mau.
Va
vt_

15. May phan tich huyet hQC;May phan tich nhorn mau.
c_
uo

16. May do dong mau; May do t6c d9 mau l~ng.

ph
inh

17. H~ thong xet nghiem Elisa.

t_b
sy

18. May chiet tach t@bao.

19. May do ngung t~p va phan tich chirc nang tiSu cau.
20. May dinh danh vi khuan, virut.
21. May phan tich miSn dich,
22. Ch~t thir, ch~t hieu chuan, v~t lieu kiSm soat in vitro.
23. Cac thi@tbi dieu tri dung tia X.
24. H~ thong phftu thuat n9i soi.
25. Cac thi@tbi X(;1
tri (May Coban diSu tri ung thu, May gia t6c tuy@ntinh
diSu tri ung thu, Dao mb gamma cac 10(;1i,
Thi@tbi X(;1 tri ap sat cac 10(;1i).
26. May theo d5i b~nh nhan.
27. Bam truySn dich; Bam tiem di~n.
28. Dao mb (di~n cao t~n, laser, sieu am).
29. Kinh hiSn vi ph~u thu~t.
30. H~ th6ng thi@tbi ph~u thu~t tiSn li~t tuy@n.
31. May tim ph6i nhan t(;1o.
32. Thi@tbi dinh vi trong ph~u thu~t.
33. Thi@tbi phftu thu~t l(;1nh.
34. L6ng ~p tre sa sinh; May suO'i~m tre sa sinh.
35. May gay me/gay me kern thO'.
36. May giup thO'.
37. May pha rung tim, t(;10nhip.
 5

38. Buong oxy cao ap,

5
4:4
39. H~ thong tan soi ngoai co the/tan soi n9i soi.

1:4
40. H~ thong thiSt bi sieu am cuong d9 cao di~u tri kh6i u.

2
22
/20
41. ThiSt bi 19C mau,

/08
42. H~ thong phftu thuat chuyen nganh nhan khoa (Laser Excimer,
01
c_
Phemtosecond Laser, Phaco, May c~t dich kinh, May cat vat giac mac).
uo
Ph

43. Kinh mat, kinh ap trong (can, viSn, loan) va dung dich bao quan kinh ap trong.
nh
Bi

44. May Laser di~u tri dung trong nhan khoa.

T
SY

45. Cac IOC;li

thiSt bi, vat li~u c~y ghep lau dai (tren 30 ngay) vao co th~.
hu
nt

46. Cac IOC;li

thiSt bi, v~t lieu can thiep vao co th~ thuoc chuyen khoa tim
t_Va

mach, th~n kinh S9 nao,

_v
c
uo

Di~u 7. Hi~u Il}'c thi hanh

ph
inh
t_b

1. Thong tu nay co hieu ltrc thi hanh k~ til' ngay 01 thang 8 nam 2022.
sy

2. Cac n9i dung quy dinh chi tiSt thi hanh mot s6 di~u cua Nghi dinh s6
98/20211ND-CP tC;liThong tu nay duqc ap dl,lng til' ngay Nghi dinh s6
98/20211ND-CP co hi~u l\fc thi hanh.
3. Mftu s6 13.01, mftu s6 13.02 quy dinh tC;liPhl,l Il,lcI va mftu quy dinh tC;li
Phl,lll,lcV cua Thong tu s6 19/20211TT-BYT ngay 16 thang 11 nam 2021 cua B9
truang B9 Y tS quy dinh mftu van ban, bao cao th\fc hi~n Nghi dinh s6
98/20211ND-CP ngay 08 thang 11 nam 2021 cua Chinh phu v~ quan Iy trang thiSt
bi y tS hSt hi~u l\fc thi hanh k~ til' ngay Thong tu nay co hi~u l\fc thi hanh.
4. Cac van ban sau day hSt hi~u l\fc thi hanh k~ tir ngay 01 thang 01 nam 2022:
a) Thong tu s6 39/2016/TT-BYT ngay 28 thang 10 nam 2016 cua B9 truang
B9 Y tS quy dinh chi tiSt vi~c phan IOC;li
trang thiSt bi y tS;
b) Thong tu s6 46/2017/TT-BYT ngay 15 thang 12 nam 2017 cua B9 truang
B9 Y tS quy dinh chi tiSt thi hanh m9t s6 di~u cua Nghi dinh s6 36/2016/ND-CP
ngay 15 thang 5 nam 2016 cua Chinh phu v~ quan ly trang thiSt bi y tS;
c) Thong tu s6 33/2020/TT-BYT ngay 31 thang 12 nam 2020 cua B9 truang
B9 Y tS quy dinh danh ml,lctrang thiSt bi y tS phai ki~m dinh an toan va tinh nang
kY thu~t;
d) Khoan 1 Di~u 1 Thong tu s6 23/20211TT-BYT ngay 09 thang 12 nam
2021 cua B9 truang B9 Y tS sua d6i, b6 sung m9t s6 van ban quy phC;lmphap lu~t
do B9 truang B9 Y tS ban hanh.
 6

Di~u 8. LQ trinh thuc hi~n

:45
1. 86i voi cac trang thiSt bi y tS quy dinh tai cac khoan 1, 2 va 3 8i~u 5

4
1:4
Thong tu nay:

22
02
a) NSu mua s~m sau ngay 31 thang 12 nam 2022 phai kiSm dinh an toan va

8/2
1/0
tinh nang ky thuat cua trang thiet bi y tS then dung quy trinh kiSm dinh do BQ
_0
oc
tnrong BQ Y tS ban hanh;
u
Ph

b) NSu mua sam truce ngay 01 thang 01 nam 2023 phai hoan thanh viec kiem
inh
TB

dinh tnroc ngay 01 thang 6 nam 2023 then dung quy trinh kiem dinh do BQtnrong
SY

BQ Y tS ban hanh.
hu
nt

2. 86i voi cac trang thiSt bi y tS quy dinh tai cac khoan 4, 5 va 6 8i~u 5
Va
vt_

Thong tir nay:

c_
uo

a) NSu mua s~m sau ngay 31 thang 12 nam 2023 phai kiSm djnh an toan va
ph
inh

tinh nang ky thuat cua trang thiSt bi y tS then dung quy trinh kiSm dinh do BQ
t_b

tnrong BQ Y tS ban hanh;

sy

b) NSu mua s~m truce ngay 01 thang 01 nam 2024 phai hoan thanh viec kiSm
dinh truac ngay 01 thang 6 nam 2024 theo dung quy trinh kiSm dinh do BQtruemg
BQ Y tS ban hanh.
Di~u 9. TB chrrc thl}'c hi~n
Chanh Van phong B9; Chanh Thanh tra B9; Vv truong, Cvc truong, T6ng
Cvc truong thu9c BQ Y tS; Giam d6c So Y tS cac tinh, thanh ph6 trllc thu9C
Trung uang va ca quan, t6 chuc, ca nhan co lien quan chiu trach nhi~m thi hanh
Thong tu nay.

r
Trong qua trinh thlJC hi~n nSu co kho khan, vuang m~c, d~ nghi cac ca quan,
t6 chuc, ca nhan phan anh kip thai v~ B9 Y tS dS xem xet, giai quySt.!

Nui nh{ln:
- Uy ban Xii hOi eila Qu6c hOi;
- Van phong Chinh phil (V\I KGVX, Cong bao, C6ng TTDT
K;H~OT~~}g::GGd)UPl
Chinh phil);
- Bo Tu phap (C\le Ki6m tra VBQPPL);
- Cae Bo, Co quan ngang Bo, Co quan thuoc Chinh phil;
- Q. Bo tru6ng Bo Y t6 (d6 b/e);
- Cae Thle truong Bo Y t6 (d6 ph6i h9P ehi d~o);
- VBND cae tinh, thimh ph6 tq.re thuoe Trung uong;
- Sa Y t6 cac tinh, thimh ph6 tn!c thuQe Trung uong;
- Sa Khoa h9C va Cong ngh~ eae tinh, thanh ph6 tn!c thuQc DB Xuan TuyeD
Trung U'ong;
- Bao hi6m Xii hQi Vi~t Nam;
- Cae don vi tn,rc thuQe BQ Y t6; y t6 cae BQ, nganh;
- Cae Vl,l,Cl,lC,T6ng Cl,lC,Van phong BQ, Thanh tra BQ;
- C6ng thong tin di~n ttr BQ Y t6;
- Luu: VT, PC, TB-CT.
 7

Phu luc I

:45
.

4
PHAN LOAI TRANG THIET BI Y TE .

1:4
(Ban hanh kern theo Thong tu s6 05 120221TT-BYT ngay 01 thang 8 ndm 2022

22
02
cua B(>truong B(>Y d)

8/2
1/0
_0
oc
u 1 Ml}.C
QUY TAc PHAN LO~I TRANG THIET BJ Y TE
Ph
inh

Ph§n I
TB

cAc DJNH NGHiA

SY
hu

Trong quy t~c nay, cac nr ngfr diroi day duoc hiSu nhu sau:
nt
Va

1. Trang thidt bi y d chit dong Ia trang thiSt bi y tS hoat dong thea nguyen
vt_
c_

t~c sir dung va bien d6i nguon nang hrong dien hoac cac nguon nang hrong khac
uo
ph

khong phai la nguon nang hrong sinh ra tir co thS con ngiroi hoac thS nang. Cac
inh

trang thiSt bi y tS str dung dS truyen nang hrong, cac ch~t hoac nhirng ySu t6 khac
t_b
sy

tir trang thiet bi y tS chu dong dSn co thS con ngiroi rna khong gay bien d6i 100
dSn cac ySu t6 nay khong duoc dinh nghia la trang thiSt bi y tS chu dong,
2. Trang thidt bi y d aiJu tri chit dong la trang thiSt bi y tS duqc su d\lng dQc
I~p ho~c kSt hqp v6i nhfrng thiSt bi y tS khac, dS h6 trq, sua d6i, thay thS ho~c
ph\lc h6i cac chuc nang ho~c c~u truc sinh h9C v6i mvc dich di~u tri ho~c giam
nhy b~nh t~t, ch~n thuang ho~c t~mt~t.
3. Trang thidt bi y d chan aoan chit a(>ngIa trang thiSt bi y tS duqc su dVng
dQc I~p ho~c kSt hqp v6i cac thiSt bi y tS khac, dS cung c~p thong tin cho vi~c phat
hi~n, chAn doan, thea d5i ho~c dS h6 trq trong di~u tri sinh Iy, tinh tr~ng suc khoe,
b~nh t~t ho~c di t~t bAm sinh.
4. L6 tren co thi la nhfrng 16 tv nhien tren co thS, bao g6m ca b~ m~t ben
ngoai nhan c~u, ho~c b~t ky 16 nhan t~o c6 dinh lau dai nhu 16 rna khi quan ho~c
16dS d~t nQi khi quan.
5. H¢ th6ng tudn hoan trung tam Ia cac m~ch mau chinh ben trong, bao g6m:
a) DQng m~ch ph6i (Arteriae pulmonales)
b) DQng m~ch chu len (Aorta ascendens)
c) DQng m~ch vanh (Arteriae cora nariae)
d) DQng m~ch canh chung (Arteria carotis communis)
d) DQng m~ch canh ngoai (Arteria carotis extema)
e) DQng m~ch canh trong (Arteria carotis intema)
g) DQng m~ch tiSu nao (Arteriae cerebrates)
h) DQng m~ch than canh tay dfiu (Truncus brachiocephalicus)
i) DQng m~ch chu ngvc (Thoracica aorta)
 8

k) Dong mach chu bung (Abdomina1is aorta)

5
1)Dong mach chau chung (Arteriae ilica communis)

4:4
1:4
m) Nga ba dong mach chu ch~u (Aorta descend ens to the bifurcatio aortae)

2
22
n) Quai dong mach chu (Arcus aorta)

/20
/08
0) TInh mach tim (Venae cordis)

01
p) TInh mach phoi (Venae pu1mona1es)
c_
uo
q) TInh mach chu tren (Venae cava superior)
Ph
nh

r) TInh mach chu diroi (Venae cava inferior)

Bi
T

6. H¢ thong thdn kinh trung uang gom nao, mang nao va tuy song.
SY
hu

7. Sit dung lien tuc trang thiet bi y tS la viec su dung trang thiet bi y tS khong
nt

bao gom b~t ky S\1'gian doan tarn thai nao trong suot qua trinh hoac b~t ky su tarn
t_Va
_v

dung sir dung trang thiet bi y tS do nham muc dich lam sach hoac khir trung hoac
c
uo

sir dung lien tiep mot trang thiSt bi y tS bang each thay thS thiet bi do ngay lap tire
ph
inh

bang mot thiSt bi cung 10~i,thea nhir chi d~n cua chu sa hiru san pham.
t_b

8. Sit dllng tc;zmthOi 1asu dVng lien tvc trong khoang thai gian it han 60 phut.
sy

9. Sir dllng trang thai gian ngan 1a su dVng lien tvc trong khoang thai gian
tu 60 phut dSn 30 ngay.
10. Sir dllng trang thOigian dai 1asu dvng lien tvc trong thm gian tren 30 ngay.
11. Nguy hidm tuc thai 1atinh hu6ng rna cac b~nh nhan g~p nguy hiSm dSn
tinh m~ng ho~c nguy hiSm dSn m9t chuc nang sinh 1y quan tn;mg nSu khong co
nhfrng bi~n phap phang ngua ngay l~p tuc.
12. Trang thiit hi y ti xam nhc;ip1a trang thiSt bi y tS xam nh~p m9t ph~n
ho~c toan b9 vao ben trong cO'thS thong qua 16tren cO'thS ho~c thong qua b~ m~t
cO'thS, bao g6m: trang thiSt bi y tS c~y ghep, trang thiSt bi y tS xam nh~p cO'thS
qua ph~u thu~t, trang thiSt bi y tS xam nh~p cO'thS qua 16 t\1'nhien va trang thiSt
bi y tS xam nh~p qua b~ m~t cO'thS.
13. Trang thiit bi y ti cay ghep la trang thiSt bi y tS duQ'c c~y, ghep thong
qua ph~u thu~t vao cO'thS ngmJi ho~c dS thay thS m9t ph~n b~ m~t biSu mo ho~c
cac b~ m~t cua m~t v6i mvc dich duy tri chuc nang cua cO'quan sau ph~u thu~t
c~y, ghep, bao g6m ca trang thiSt bi y tS duQ'c dung dS dua m9t ph~n vao cO'thS
thong qua S\1'can thi~p cua ph~u thu~t v6i mvc dich duy tri chuc nang cua cO'quan
sau ph~u thu~t c~y, ghep trong yang it nh~t 30 ngay.
14. Trang thiit bi y ti xam nhc;ipqua phdu thuc;it1atrang thiSt bi y t~ xam nh?P
duQ'cdua vao cO'thS thong qua b~ m~t cua cO'th~ vai Sl,fh6 trQ'cua ph~u thu?t, bao
g6m ca cac trang thiSt bi xam nh?P vao cO'thS khong qua cac 16 tv nhien.
 9

15. Trang thiit bi y ti chdn doan in vitro tic xet nghiem la trang thiSt bi y tS
sa

5
chan dean in vitro diroc chu hfru chi dinh Slr dung cho nhtrng nguoi chua duoc

4:4
1:4
dao tao vS linh V\IC lien quan.

22
02
16. Xet nghiem tai ch61a xet nghiem diroc thuc hien ngoai phong xet nghiem

8/2
cua co sa
kham chua benh hoac trung Him chuyen nghiep, co thS duoc thuc hien

1/0
_0
tai giirong benh hoac tai noi sinh song cua benh nhan.
c
uo
Ph

17. Thu6c thu la cac chdt hoa hoc, sinh hoc, mien dich hoc, cac dung dich
inh

hoac che pham diroc chu sa

htru chi dinh sir dung nhu trang thiSt bi y tS ch&ndoan
TB

in vitro.
SY
thu

18. Vdt chua mJu la trang thiet bi y tS ch&n doan in vitro, loai chan khong
n

sa
Va

hoac khong, duoc chu hfru chi dinh chi dung dS d\fllg m~u ph&m co ngu6n g6c
vt_

tir co thS nguai.

_
oc
u

19. Tac nhan co thd lay truy~n la m(>ttac nhan co kha nang truySn cho nguai
ph
inh

nhu b~nh co thS lay, nhiSm.

t_b
sy

20. S1! lay truy~n la truySn b~nh cho nguai.

21. Trang thiit bi h6 tr(1 ho¢c duy tri S1! s6ng la m(>ttrang thiSt bi y tS ccln
thiSt ho~c t?O ra thong tin ccln thiSt cho vi~c phvc h6i va duy tri m(>tchuc nang
quan tr<;>ngcua co thS d6i vai vi~c duy tri cUQcs6ng cua con nguoi

PhAn II
QUY TAc PHAN LO~I DOl VOl TRANG THIET BI Y TE
KHONG PHAI TRANG THIET BI Y TE CHAN DoAN IN VITRO

A. QUY TAc PHAN LO~I DOl Val TRANG THIET BI Y TE

KHONG xAM NH~P
Quy t~c 1. Phan lo~i cho trang thi~t bi Y t~ ti~p xuc vOi da tAn thuO'ng
1. T&tca cac trang thiSt bi y tS khong xam nh~p tiSp xuc v6i cac vSt thuong
ngoai da thuQc lo?i A nSu duQ'c Slr dVng nhu mQt rao ch~n co h<;>c,chi v6i chuc
nang lam co d<;>ngho~c th&mhut dich v6i mvc dich lam lanh ban dcluvSt thuong.
2. Trang thiSt bi y tS khong xam nh~p duQ'c Slr dVng chu ySu v6i cac vSt
thuong xuyen qua lap h? bi, bao g6m cac trang thiSt bi y tS dUQ'cSlr dVng v6i mvc
dich chu ySu dS kiSm soat vi moi truang cua vSt thuong thuQc lo?i B.
3. Trang thiSt bi y tS khong xam nh~p duQ'cSlr dvng chu ySu vai cac vSt thuong
xuyen qua lap h? bi va chi duQ'cchua lanh b~ng bi~n phap khac thuQc lo?i C.
Quy t~c 2. Phan lo~i cho trang thi~t bi Y t~ khong xam nh~p sir d1}ngd~
truy~n ho~c bao quan
T~t ca cac trang thiSt bi y tS khong xam nh~p su dVng cho vi~c truySn ho~c
chua cac lo?i dich co thS, mo, ch~t long ho~c khi vai mvc dich cu6i cung 1:1truySn,
 10

uong hoac dua vao co thS duoc phan vao loai A neu khong thuoc cac tnrong hop

5
sau:

4:4
1:4
1. Cac trang thiSt bi y tS co the kSt noi voi trang thiSt bi y tS chu dong thuoc

2
22
loai B hoac cao han thuoc loai B.

/20
/08
2. Cac trang thiSt bi y tS diroc S11 dung dS truyen mau, bao quan hay truyen

01
c_
cac dich khac cua co thS hoac bao quan cac b9 phan, cac phan cua b9 phan hoac
uo
Ph

mo co thS thuoc loai B.

nh
Bi

3. Tui mau thuoc loai C.

T
SY

Quy t~c 3. Phan loai cho trang thi~t hi Y t~ khong xam nh~p co chirc
hu

nang chuyen aAi hoa - sinh

nt
Va

Cac trang thiet bi y tS khong xam nhap diroc dung dS thay d6i thanh phan
t_
_v

hoa hoc hoac sinh hoc cua mau, dich co thS ho~c cac lo?i dich khac dS truy@nvao
c
uo
ph

co thS thuQc lo?i C. Tril' khi vi~c di@utri bao g6m lQc, ly tam ho~c trao d6i khi
inh

ho~c nhi~t, truemg hqp nay thu9C lo?i B.

t_b
sy

Quy t~c 4. Phan lo~i cho trang thi~t hi Y t~ khong xam nh~p khac
T~t ca cac trang thiSt bi y tS khong xam nh~p khac thuQc lo?i A.
B. QUY TAc PHAN LO~ DOl v6I TRANG THIET BI y rt tiM ~
Quy t~c 5. Phan lo~i trang thi~t hi Y t~ xam nh~p thong qua 18 cua cO'
th~ khong qua ph~u thu~t
1. Cac trang thiSt bi y tS xam nh~p thong qua cac 16 cua co thS khong qua
ph~u thu~t, khong duqc su dVng dS kSt nbi vai cac lo?i trang thiSt bi y tS chu d9ng
ho~c chi kSt nbi vai trang thiSt bi y tS lo?i A thuQc lo?i A nSu cac trang thiSt bi y
tS nay duqc S11 dVng t?m thoi Trong tfUemghqp trang thiSt bi y tS thu9C lo?i nay
duqc S11 dVng tren b@m~t co thS, nhan c~u ho~c co kha nang h~p thv boi niem
m?c thu9C lo?i B.
2. Cac trang thiSt bi y tS xam nh~p thong qua cac 16 cua co thS khong qua
ph~u thu~t, khong duqc S11 dVng dS kSt n6i vai cac lo?i trang thiSt bi y tS chu d9ng
ho~c chi kSt n6i vai trang thiSt bi y tS lo?i A thu9C lo?i B nSu cac trang thiSt bi y
tS nay duqc S11 dVng trong thai gian ngiln. Trong truemg hqp trang thiSt bi y tS nay
duqc S11 dVng trong vung co thS til' khoang mi~ng dSn h~u, til' bc tai dSn mang nhI
ho~c trong khoang mlii thi duqc xSp vao lo?i A.
3. Cac trang thiSt bi y tS xam nh~p thong qua cac 16 cua co thS khong qua
ph~u thu~t, khong duqc S11 dVng dS kSt n6i vai cac lo?i trang thiSt bi y tS chu dQng
ho~c chi kSt n6i vai trang thiSt bi y tS lo?i A thu9C lo?i C nSu cac trang thiSt bi y
tS nay duqc S11 dVng trong thai gian dai. Trong truemg hqp trang thiSt bi y tS nay
duqc S11 dVng trong vung co thS til' khoang mi~ng dSn h~u, til' bc tai dSn mang nhI
 11

hoac trong khoang miii va khong co kha nang h~p thu boi niem mac thi duoc x@p

5
vao loai B.

4:4
1:4
4. T~t ca cac trang thiet bi y t@xam nhap thong qua cac 16 cua co thS (tnr

2
22
nhfrng xam nhap bang ph~u thuat) diroc dung dS ket n6i voi mot thi@tbi y t@chu

/20
/08
dong thuoc loai B hoac cao han duoc x@pvao Ioai B.

01
c_
Quy t~c 6. Phan loai trang thi~t b] Yt~ xam nh~p qua phfiu thu~t sir dung
uo
tam thiri
Ph
nh

T~t ca cac trang thi@tbi y t@xam nhap qua ph~u thuat sir dung tam thai thuoc
Bi
T

loai B, neu khong thuoc cac tnrong hQ'Pduoi day:

SY
hu

1. Cac trang thi@tbi y t@la cac dung cu ph~u thuat tai su dung thuoc loai A.
nt
Va

2. Cac trang thi@tbi y t@dung dS cung c~p nang luQ'llgdu6i dtilngbuc xtilion
t_
_v

hoa thu9C lotiliC.

c
uo
ph

3. Cac trang thi@tbi y t@dung dS ttil0ra tac d\lng sinh hQc ho~c dS h~p th\l
inh
t_b

hoan toan hay ph~n Ian thu9C lotiliC.

sy

4. Cac trang thi@tbi y t@dung dS dua cac san ph~m thu6c vao cO'thS b&ngh~
th6ng v~n chuySn rna cach th\l'c hi~n nay co kha nang gay nguy hiSm khi ap d\lng
duQ'cx@pvao lotiliC.
5. Cac trang thi@tbi y t@duQ'c chi dinh C\lthS su d\lng co ti@pxuc tr\l'Cti@p
v6i h~ th~n kinh trung uang thu9C lotiliD.
6. Cac trang thi@tbi y t@ duQ'c chi dinh C\lthS dS ch~n doan, thea d5i ho~c
sua chua khuy@tt~t cua tim ho~c cua h~ tu~n hoan trung tam b&ng cach ti@pxuc
tr\l'c ti@pv6i cac b9 ph~n nay cua cO'thS thu9C lotiliD.
Quy t~c 7. Phan lo~i trang thi~t bi Y t~ xam nh~p qua phfiu thu~t Slf
dl)ng trong thOi gian ng~n
T~t ca cac thi@tbi y t@ph~u thu~t xam nh~p su d\lng trong thai gian ng~n
thu9C lotiliB n@ukhong thu9C cac truang hQ'Psau:
1. Cac trang thi@tbi y t@duQ'csu d\lng dS cung c~p cac san ph~m thu6c thu9c
lotiliC.
2. Cac trang thi@tbi y t@duQ'csu d\lng phai trai qua nhilng chuySn d6i hoa hQc
trong cO'thS nguai (tm truang hQ'Pthi@tbi duQ'cd~t trong rang) thu9C lotiliC.
3. Cac trang thi@tbi y t@su d\lng dS cung c~p nang luQ'llgdu6i dtilngbuc xtil
ion hoa thu9C lotiliC.
4. Cac trang thi@tbi y t@duQ'c su d\lng dS ttil0ra m9t hi~u ling sinh hQc ho~c
bi h~p th\l hoan toan hay ph~n Ian thu9C lotiliD.
5. Cac trang thi@tbi y t@ti@pxuc tr\l'c ti@pv6i h~ th~n kinh trung uang thu9c
lotiliD.
 12

6. Cac trang thiet bi y tS duoc chi dinh cu thS dS ch~n doan, thea doi hoac

:45
sua chua mot khuyet t~t cua tim hoac cua h~ thong tu~n hoan trung Himbang each

:44
tiep xuc true tiep voi cac bQ phan nay cua co thS thuoc loai D.

21
22
Quy t~c 8. Phan loai trang thi~t b] Y t~ xam nh~p qua ph~u thu~t sir

/20
/08
dung trong thm gian dai va trang thi~t b] Y t~ c~y ghep

01
c_
T§.tca cac trang thiSt bi y tS xam nhap qua ph~u thuat sir dung trong thai gian
uo
dai va trang thiSt bi y tS c§.yghep thuoc loai C nSu khong thuoc cac twang hQ'Psau:
Ph
inh

1. Cac trang thiSt bi y tS duoc str dung dS dat vao rang thuoc loai B.
TB
SY

2. Cac trang thiet bi y tS khi su dung tiSp xuc trvc tiSp v6i tim, h~ tu~n hoan
hu

trung tam ho?c h~ th~n kinh trung uang thuQc IO<;liD.

nt
Va

3. Cac trang thiSt bi y tS su d\lng dS h6 trQ'ho?c duy tri S\l s6ng thuQc IO<;li
D.
vt_
c_

4. Cac trang thiSt bi y tS d6ng thai la trang thiSt bi y tS chu d(>ng thu(>c
uo
ph

IO<;li
D.
inh
t_b

5. Cac trang thiSt bi y tS duQ'c su d\lng co tac d\lng sinh h9C ho?c h§.p th\l
sy

hoan toan hay ph~n Ian thuQc IO<;liD.

6. Cac trang thiSt bi y tS duQ'csu d\lng dS cung c§.pcac san phk thu6c thuQc
IO<;li
D.
7. Cac trang thiSt bi y tS khi duQ'csu d\lng phai trai qua nhfrng chuySn d6i hoa
h9Ctrong co thS nguai (tm truang hQ'PthiSt bi duQ'cd?t trong rang) thu(>cIO<;li D.
8. Cac trang thiSt bi y tS thuQc quy t~c nay duQ'c su d\lng dS c§.yghep ng\lc
thuQc IO<;li
D.
c.QUYTACPHANLO~OOIVmTRANGTHIETBJYTECHiJD(>NG
Quy t~c 9. Phan lo~i trang thi~t bi Y t~ oi~u tri chu oQng
T§.tca cac trang thiSt bi y tS diSu tri chu dQng nh~m m\lc dich phan ph6i ho?c
trao d6i nang IUQ'llgthuQc IO<;li B nSu khong thuQc cac twang hQ'Psau:
1. Cac trang thiSt bi y tS diSu trj chu dQng co chuc nang phtin ph6i ho?c trao
d6i nang IUQ'llgt6i ho?c tir co thS con nguai thea cach co thS gay rui ro, bao g6m
phat buc X<;l
ion hoa co tinh dSn tinh ch§.t,m~t dQva vi tri ap d\lng cua nang IUQ'llg
duQ'cxSp vao IO<;liC.
2. Cac trang thiSt bi y tS chu d(>ngnh~m kiSm SOat, thea d6i ho?c co anh huemg
tf\lCtiSp dSn hi~u nang cua trang thiSt bi y tS diSu tri chu dQng IO<;li
C thuQcIO<;li
C.
Quy t~c 10. Phan lo~i trang thi~t hi Y t~ chu oQng dung o~ chAn omin
1. Cac trang thiSt bi y tS dUQ'csu d\lng dS chiSu sang co thS b~nh nhan vai
anh sang thuQc vling quang ph6 nhin th§.y dUQ'cho?c g~n vung quang ph6 hfmg
ngo<;liduQ'cxSp vao IO<;li
A.
 13

2. Cac trang thiet bi y tS chu dong dung dS chan doan la loai B nSu thuoc cac

:45
tnrong hop sau:

:44
a) Duoc su dung dS cung c~p nang hrong h~p thu van co the con nguoi (trir

21
22
cac trang thiSt bi y tS duoc quy dinh a muc a);

/20
/08
b) Duoc sir dung dS chup su phan phoi cac thuoc co chua phong xa trong

01
c_
co thS ngiroi; uo
Ph

c) Duoc sir dung dS chan doan true tiSp hoac giam sat qua trinh sinh ly
inh

hoc cua sir song,

TB
SY

3. Cac trang thiSt bi y tS chu dong dung dS chan doan diroc xSp van loai C
hu

neu thuoc mot trong cac tnrong hop sau:

nt
Va

a) Duoc sir dung dS giam sat cac thong s6 sinh ly hoc cua sir song khi rna sir
vt_
c_

thay d6i cac thong s6 nay co thS d~n dSn tinh tr~ng nguy hiSm cho b~nh nhan, vi dV
uo
ph

nhu ho~t d9ng cua tim, ho h~p, ho~t d9ng cua h~ th§.nkinh trung uang.
inh
t_b

b) Bugc su dVng dS ch~n doan trong cac tinh hu6ng lam sang khi b~nh nhan
sy

dang trong tinh tr~ng nguy hiSm.

4. Trang thiSt bi y tS chu d9ng dugc su dVng dS phat buc x~ ion hoa va dugc
su dVng dS ch~n doan va;ho~c can thi~p bAng X quang, bao g6m ca cac trang thiSt
bi y tS kiSm soat, thea d6i cac trang thiSt bi y tS nhu v~y ho~c nhUng thiSt bi tf\l'C
tiSp anh huang dSn ho~t d9ng cua chung dugc xSp van lo~i C.
Quy tic 11. Philn lo~i trang thi~t bi Y t~ chu dQng co chfrc nang cung
c~P' lo~i bo thuBc, dich cO'th~ va cac ch~t khac vao cO'th~ ho~c dU'a tir cO'th~
ra ngoai
T~t ca cac trang thiSt bi y tS thu9c quy t~c nay dugc xSp van lo~i B. Truang
hqp cac trang thiSt bi y tS nay co nguy cO'gay nguy hiSm cho b~nh nhan do ban
ch~t cua cac ch~t dugc su dVng, ph§.ncO'thS lien quan cling nhu cach thuc va duang
cung c~p ho~c lo~i b6 thu6c, dich cO'thS, cac truang hqp nay dugc xSp van lo~i C.
Quy tic 12. Philn lo~i trang thi~t bi Y t~ chu dQng khac
T~t ca cac trang thiSt bi y tS chu d9ng khac dugc xsp van lo~i A.
D. cAc QUY TAc PHAN LO~I KHAc
Quy tic 13. Philn lo~i trang thi~t bi Y t~ k~t hQ'p dU'Q'cch~t
Cac trang thiSt bi y tS nSu dugc kSt hqp v6i dugc ch~t nhAm m\lc dich h6 trg
cho trang thiSt bi y tS do ho~t d9ng tren ho~c trong cO'thS nguai thi dugc xSp van
lo~i D.
Quy tic 14. Phan lo~i trang thi~t bi Yt~ co nguAn gBctir dQng v~t, vi khuAn
1. Cac trang thiSt bi y tS dugc xSp van lo~i D nSu co thanh ph§.n thu9c m9t
trong cac truang hqp sau:
 14

a) TS bao, mo cua dong v~t va cac d~n xu~t cua chung rna khong the phat

5
triSn doc lap;

4:4
1:4
b) TS bao, mo, cac d~n xuat co nguon g6c vi khuan hoac tai t6 hop.

2
22
2. Truong hop cac trang thiet bi y tS neu co thanh phan tir mo dong v~t hoac

/20
/08
d~n xuat mo dong v~t va khong thS phat triSn dQc lap nSu chi duoc sir dung bang

01
c_
each tiep xuc voi da khong bi thuong thi diroc xep vao loai A.
uo
Ph

Quy t~c 15. Phan loai trang thi~t b] y t~ khir khuan, ti~t khuan
nh
Bi

1. Trang thiSt bi y tS su dung dStiet khuan trang thiSt bi y tS duoc xSp vao loai C.
T
SY

2. Trang thiet bi y tS su dVng d~ khu khufin trang thiSt bi y ts rna vi~c khu
hu
nt

khufin dola giai dOl;lncU6i cung cua quy trinh khu khufin thi duQ'cxSp vao lOl;liC.
t_Va

3. Trang thiSt bi y tS duQ'c su dVng dS khu khufin trang thiSt bi y ts rna vi~c
_v
c

khu khufin do duQ'cth\Ic hi~n truac khi ti~t khufin thi duQ'cxSp vao IOl;liB.
uo
ph

4. Trang thiSt bi y tS duQ'csu dVng dS khu khufin rna vi~c khu khufin do duQ'c
inh
t_b

th\Ic hi~n truac khi khu khufin 6 giai dOl;lncu6i cimg thi dUQ'cxSp vao IOl;liB.
sy

5. Trang thiSt bi y tS duQ'cchi dinh dS khu khufin, lam Sl;lch,ngam, rua ho~c
du6ng fim kinh ap trong duQ'cxSp vao lOl;liC.
Quy t~c 16. Phan lo~i trang thi~t bi y t~ dung d~ tranh thai hay phong
chang cac b~nh lay nhi~m qua dtfrrng tinh dt}.c
1. Trang thiSt bi y tS dung dS tranh thai hay phong ch6ng cac b~nh lay nhi~m
qua dUOngtinh dvc duQ'cxSp vao IOl;liC.
2. TruOng hqp trang thiSt bi y tS dung dS tranh thai hay phong ch6ng cac
b~nh lay nhi~m qua dUOngtinh dvc la trang thiSt bi y tS xam nh~p su dVng trong
thai gian dai ho~c c~y ghep duQ'cxSp vao lOl;liD.

Phin III
QUY TAC PHAN LO~I DOl Val
TRANG THIET BI Y TE CHAN DoAN IN VITRO

Quy t~c 1. Trang thi~t bi y t~ ch~n doan in vitro sir dt}.ngcho mQt trong
cac mt}.cdich sau thi dtfgc x~p vao lo~i D
1. SU dVng dS phM hi~n S\Ihi~n di~n ho~c S\I phoi nhi~m vai mQt tac nhan
lay nhi~m trong mau, thanh ph~n mau, d~n xu~t mau, tS bao, mo ho~c cac bQph~n
co th~ nguai nh&m danh gia S\Iphu hqp cua chung d~ th\Ic hi~n truy~n mau ho~c
c~y ghep.
2. SU dVng dS phM hi~n S\Ihi~n di~n ho~c S\I phoi nhi~m vai mQt tac nhan
lay nhi~m rna tac nhan do gay ra b~nh de d(;mdSn tinh ml;lng, thuOng khong co
kh{lnang chua tri vai nguy co lay truy~n cao.
 15

Quy t~c 2

5
Trang thi@tbi y t@chan doan in vitro duoc sir dung dS xac dinh nhom mau

4:4
1:4
hoac phan loai mo dS bao dam nrong thich miSn dich cua mau, thanh phan mau,

2
22
cac t@bao, mo hoac bQ phan co thS dS thuc hien truyen mau hoac cay ghep thi

/20
duoc x@pvao loai C, tnr trang thi@tbi y t@sir dung dS xac dinh nhom mau he ABO

/08
01
[A (ABOI), B (AB02), AB (AB03)], h~ rhesus [RHI (D); Rh2 (C), Rh3 (E),
c_
uo
RH4 (c), RH5( e)], h~ Kell [Kell (K)], h~ Kidd [JKI (Jka), JK2 (Jkb)] va h~ Duffy
Ph
nh

[FYI (Fya), FY2 (Fyb)] duoc x@pvao loai D.

Bi
T

Quy t~c 3. Trang thi~t b] Y t~ chin doan in vitro Stf dung cho mQt trong
SY

cac muc dich sau thi dU'Q'cx~p vao loai C

hu
nt
Va

1. Phat hien sir hien dien hoac phoi nhiem voi tac nhan lay truyen qua duong
t_

tinh due (vi du nhlrng b~nh lay truySn qua duemg tinh dvc, Chlamydia
_v
c
uo

trachomatis, Neisseria gonorrhoeae).

ph
inh

2. Phat hi~n SlJ hi~n di~n cua tac nhan truySn nhiSm trong dich nao tuy ho~c
t_b

mau vai kha nang lay truySn h(;ln ch@ (vi dV Neisseria meningitidis ho~c
sy

Cryptococcus neoformans).
3. Phat hi~n sv hi~n di~n cua tac nhan truySn nhiSm rna khi k@tqua xet
nghi~m sai co nguy cO'r~t Ian d~n d@ntu vong ho~c khuy@tt~t nghiem tn;mg cho
ca nhan ho~c thai nhi duQ'c xet nghi~m (vi dV xet nghi~m ch~n doan CMV,
Chlamydiapneumoniae, Staphylococcus aureus khang Methycillin).
4. Sang lQc truac sinh dS xac dinh tinh tr(;lngmiSn dich d6i vai cac tac nhan
gay b~nh truySn nhiSm (vi dV kiSm tra tinh tr(;lngmiSn dich d6i vai Rubella ho~c
Toxoplasmosis ).
5. Xac dinh tinh tr(;lngb~nh truySn nhiSm ho~c tinh tr(;lngmiSn dich rna k@t
qua xet nghi~m sai co thS d~n d@nnguy cO'de dQa tinh m(;lngb~nh nhan trong thai
gian g~n do quy@t dinh diSu tri khong phil hQ'P (vi dv xet nghi~m ch~n doan
a
Enterovirus, CMV va HSV b~nh nhan duQ'cc~y ghep).
6. Sang lQc Iva chQn b~nh nhan dS ap dVng bi~n phap quan ly va li~u phap
diSu tri phil hQ'Pho~c dS xac dinh giai dO(;lncua b~nh ho~c ch~n doan ung thu (vi
dVy hQc ca thS hoa).
Cac trang thi@tbi y t@ch~n doan in vitro rna quyst dinh diSu tri thuemg chi
duQ'cdua ra sau khi co danh gia sau han va nhfrng thiSt bi y t@ch~n doan in vitro
dUQ'csu dVng dS thea d5i se thuQc lO(;liB thea quy t~c 6 - Ph~n III.
7. Xet nghi~m gen di truySn a ngum (vi dVnhu b~nh Huntington, XO'nang).
8. Theo d5i n6ng dQthu6c, cac ch~t ho~c cac thanh ph~n sinh hQCrna kSt qua
xet nghi~m sai co thS d~n dSn nguy cO'de dQa tinh m(;lngb~nh nhan ngay ttrc thi
 16

do quyet dinh dieu tri khong phu hop (vi du nhir cac d~u hieu tim mach,

:45
cyclosporin, xet nghiem thai gian dong mau),

4
1:4
9. Theo doi, di~u tri benh nhan bi benh truyen nhiem de doa tinh mang (vi

22
02
du nhu tai hrong virus HCV, tai hrong virus HIV va xac dinh ki~u gen, phan nhom

8/2
ki~u gen HIV, HCV).

1/0
_0
10. Sang loc r6i loan barn sinh
oc
u a thai nhi (vi du nhu t~t mrt d6t song hoac hoi
chirng Down).
Ph
inh

Quy t~c 4
B
YT

1. Trang thiSt bi y tS ch~n doan in vitro tu xet nghiem duoc phan vao loai C.
S
hu

Truong hop kSt qua xet nghiem cua trang thiet bi y tS ch~n doan in vitro khong
nt
Va

phuc vu quyet dinh di~u tri hoac chi co gia tri tham khao va c~n thtrc hien xet
vt_

nghiem b6 sung phu hop tai phong xet nghi~m thi trang thiSt bi nay thu<)clo~i B.
c_
uo
ph

2. Trang thiSt bi y tS ch~n doan in vitro dung d~ xet nghi~m t~i ch6 thong s6
inh

khi mau va dUOng huySt thu<)c lo~i C. Cac trang thiSt bi y tS ch~n doan in vitro
t_b
sy

xet nghi~m t~i ch6 khac duQ'cphan lo~i d\Ia tren cac quy t~c phan lo~i tuang ling.
Quy t~c 5. Cac trang thi~t bi y t~ ch~n doan in vitro dugc phao vao lo~i
A n~u thuqc mqt trong cac trU'O'nghgp sau:
1. Cac san ph~m khac tham gia ho?c h6 trQ'qua trinh th\Ic hi~n xet nghi~m
duQ'cchu sa hfru chi dinh dung cho cac quy trinh ch~n doan in vitro lien quan dSn
xet nghi~m C\lth~.
2. Trang thiSt bi y tS duQ'c chu sa hfru chi dinh su d\lng trong cac quy trinh
ch~n doan in vitro.
3. V~t chua mfru.
Quy t~c 6. Trang thi~t bi y t~ ch~n doan in vitro khong thuqc quy t~c 1
" ,
den quy tac 5 dU'gc phan van lo~i B.
Quy t~c 7. Trang thi~t bi Y t~ ch~o doan in vitro la cac v~t Ii~u ki~m soat
khong dU'gc gan gia tri dinh lU'gng ho~c djnh tinh thuqc lo~i B.

Muc2
QUY TA.C PHAN NHOM DANG KY s6 LUU HANH
TRANG THIET BI Y TE

Trang thiSt bi y tS co th~ phan thea trang thiSt bi y tS dan Ie ho?c nhom trang
thiSt bi y tS nhu sau:
a) HQ trang thiSt bi y tS (sau day gQi t~t la hQ);
b) B<)trang thiSt bi y tS ch~ doan in vitro (sau day gQi~t la b<)IVD);
c) H~ th6ng trang thiSt bi y tS (sau day gQi t~t la h~ th6ng);
 17

d) Cum trang thiet bi y tS chan doan in vitro (sau day goi t~t la cum IVD);

5
4:4
d) BQ trang thiSt bi y tS khac (sau day goi t~t la bo).

1:4
1. Nguyen t~c phan theo trang thi~t b] y t~ don le

2
22
/20
Trang thiet bi y tS duoc phan thea trang thiet bi y tS dan le nSu trang thiSt bi

/08
y tS do da diroc chu so hiru xac dinh ten, muc dich su dung cu thS va diroc cung

01
c_
c~p duoi dang dong goi rieng biet hoac trang thiSt bi y tS do khong dap irng cac tieu
uo
Ph

chi phan thea ho trang thiSt bi )' tS, bQ IVD, h~ thong trang thiSt bi y tS, cum trang
nh

thiSt bi y tS IVD hoac bQtrang thiet bi y tS khac,

TBi
SY

2. HQ trang thi~t b] y t~
hu

HQ trang thiSt bi y tS la mot t~p hop cac trang thiSt bi y tS rna rn6i trang thiSt
nt
Va

bi y tS trong hQ dSu co chung cac thong tin sau:

t_
_v
c

- Cung mQt chu so hfru san ph~rn;

uo
ph

- Cung mQt lo~i phan 10~irui ro;

inh
t_b

- Co cung ffi\lCdich su d\lng;

sy

- Co thiSt kS va quy trinh san xu~t gi6ng nhau;

- Co nhCingthay d6i thuQcph~ vi cac biSnthScho phep thea danh m\lc ~ Bang 1.

Bang 1. Danh m\lc cac bi~n th~ cho phep trong mQt trang thi~t bi Yt~ theo hQ
San phim c\l th~ Cac bi~n th~ cho phep
Tfl,lc~y ghep nha khoa Ph~n gifr (vi d\l: xi mang ho~c 6c vit)
Trang thiSt bi c~y ghep SU d\lng dugc vai thiSt bi cQng huang tir ho~c khong
chu dQng
Xet nghi~m ch~t N6ng dQ
khang sinh (IVD)

Kim sinh thiSt D~ng c6 dinh ho~c khong c6 dinh

Tlii mau (i) Ch~t chfmg dong mau cung thanh ph~n nhung co
thS khac n6ng dQ
(ii) Cac ch~t ph\! gia (Khac thanh ph~n va khac n6ng dQ)

Ong thong (i) S6 lugng lumen trong 6ng thong

(ii) Ch~t li~u cua 6ng thong: PVC (polyvinylchloride),
PU (polyurethane), nylon va silicone
(iii) DQ cong
(iv) Ch~t phu dung dS boi tran

Bao cao su (i) KSt cau

 18

(ii) Mui

:45
Kinh ap trong (i) Di-6p

4
1:4
(ii) Chong tia eire tim

22
02
(iii) Phil mau

8/2
1/0
(iv) Mau s~c
_0 (v) Thai gian sir dung (deo ban ngay hay den keo dai)
oc
u
Ph

(vi) Thai gian thay kinh (hang ngay, tu~n hay thang)
inh
TB

May khir rung Ttr dong boac ban tu dong

SY
hu

Nieng rang Ch~t lieu cua nieng fang

nt
Va

Tay khoan nha khoa (i) T6c dQ quay

vt_
c_

(ii) Ch~t lieu cua tay khoan

uo
ph
inh

Ch~t lam d~y da Cung thanh phan nhung khac nong dQI mat dQ
t_b
sy

H~ thong chup chftn (i) S6 lat c~t

doan dung birc xa ion- (ii) Ky thuat s6 hoac nrong tu (thuong quy)
hoa (iii) Hai binh dien hay mot binh dien
(iv) SU dung bQthu nhan phang hay Cassette
(v) Kich tlnroc vong thu nhan (d6i voi PET)
Ong thong tham do (i) Khoang each gifra cac dien eire
dien sinh ly (ii) S6 hrong dien eire
Gang tay Co bQt hoac khong
Camera Gamma S6 d~u thu
Day d~n Co hoac khong co v~t lieu phil tro
C~y ghep chinh hinhl (i) C6 dinh bang xi mang hoac khong
nha khoa (ii) Vong dai
Thily tinh thS nhan t~o (i) Don tieu Cll ho~c da tieu Cll
(ii) NhiSu manh ho~c don manh
(iii) Hinh c~u ho~c phi c~u
May phat sung c~y ghep S6 bu6ng tim (tim m~ch)
6ng thong IV (i) Co bu6ng tiem
(ii) Co canh an toan
Xet nghi~m nhanh IVD Dinh d~ng t6 hqp khac nhau: khay, que, but, 6ng,
thanh, the
 19
?

Que thir nu6c tieu Test thir co kSt hop nhieu thong s6

:45
trong 6ng nghiem

:44
21
San pham polymer Co ho~c khong co chat him deo hoa (vi du:

22
/20
diethylhexyl phtalat)

/08
Khung gia dO'(stent) (i) H~ thong dua stent, d~t qua day dftn hoac d~t qua
01
c_ 6ng noi soi
uo
Ph

(ii) Vat (mb dS ghep) hoac 6ng ngoai

inh
TB

Chi khau (i) S6 hrong soi

SY
hu

(ii) Gac
nt
Va

(iii) Vong
vt_
c_

(iv) Nhuom
uo
ph

Dung cu xau chi khan

inh

ThiSt kS ham kep, tay c~m va kim

t_b
sy

Ongkhiqulin(ongnQikhi Co hoac khong co bong

qulin,6ng rna khi qulin)
Bang vSt thuong Cac dang khac nhau (vi du: dung dich, kern, gel, phil
tren cac mieng lot ... )
D~u thu su dung tia X V~t lieu phat tia X (trong b~u tang quang)

Danh muc cac bi~n th~ chung khac cho phep trong mQt trang thi~t b] Yt~ theo HQ:
Chat phil chi dung dS boi tron
Mau sAc
Duong kinh, chi~u dai, chi~u rong, cO'
Nong dQ voi cling mot chi dinh va co chS (co cling thanh ph~n, luqng ySu t6
cfiu thanh khac nhau)
Khac bi~t v~ thiSt kS kich thuac do su dVng cho tre em so vai cho nguai IOn
(Nhfrng khac bi~t nay la do khac bi~t v~ nhom b~nh nhan duQ'cphep su dVng,
vi dv, thS tich va chi~u dai)
DQ linh ho~t
--
L\fc c~m nAm
Muc ho~t dQ phong x~ cua d6ng vi
Luu tru bQ nh6
Phuong phap khu trling (dS d~t duQ'ccling mQt kSt qua vo trung)
Kha nang in
 20

Tinh chin birc xa

:45
Hinh dang, kich thiroc, thS tich

4
1:4
su thay

22
DQ nhot (Sir thay d6i dQ nhot don thuan chi la do d6i trong nong dQ

02
cua chftt cftu thanh)

8/2
1/0
Hinh thirc treo (vi du: treo tran, treo nrong hoac chan dirng)
_0
oc
Trang thai vo bung (tiet trung, khong ti~t trung)
u
Ph
inh
TB
SY
hu
nt
Va
vt_
c_
uo
ph
inh
t_b
sy
 21

SO' dB phan nhom cac traog thi~t b] y t~ theo hQ

:45
:44
21
22
/20
Khong

/08
01
c_
uo
Ph
inh
TB
SY

Khong
hu
nt
Va
vt_
c_
uo
ph
inh
t_b

Khong
sy

Khong
Cling thiet k~ va
quy trinh
san xuat?

Diem khac nhau Khong

nam trong danh Khong lei ho trang
muc bien the thiSt bi y tS
cho phep?

Co
HQ trang thiet bi y tS
(cac thanh phan trong ho duoc liet ke
rieng thea ten san pham)
 22

3. BQ trang thi~t hi Y t~ chAn doan in vitro

:45
BQ IVD la mot t~p hop cac trang thiSt bi y tS ch~n doan in vitro bao g6m

:44
thu6c thir hoac nlnrng san pham co chung cac thong tin sau:

21
22
- Diroc cung cAp tir cling mot chu so hiru san pham;

/20
/08
- Diroc sir dung kSt hop voi nhau d~ hoan thanh mot muc dich su dung cu th~;

01
c_
- Diroc cung cAp duoi mot ten la bQ IVD hoac tren nhan, tai lieu huang d~n
uo
Ph

sir dung cua m6i loai thuoc thir hoac san pham chi ra thanh phan do duoc sir dung
inh

cling voi bQ IVD;

TB
SY

- Tuong thich khi diroc sir dung nhir mot be>IVD.

hu

MQt bQ IVD khong bao gom thiet bi nhir may xet nghiem c§.ncho viec thuc
nt
Va

hien xet nghiem, h~ thong trang thiStbi y tSch~ doan invitro co th~ bao g6m cac be>
vt_

IVD va thiSt bi (vi d\l: May xet nghi~m dugc thiSt kS d~ su d\lng v6i be>xet nghi~m).
c_
uo
ph

M6i lo(;lithu6c thu ho~c san ph~m trong bQ IVD co th~ duQ'ccung cAprieng
inh

cho bQ IVD d~ thay thS. NSu thu6c thu ho~c san ph~m trong mQt bQ IVD duQ'c
t_b
sy

cung cAp d~ su d\lng cho nhiSu bQ IVD khac thi cac thu6c thu ho~c san ph~m do
phai duQ'c dang kY cling v6i m6i bQ IVD khac nhau ho~c co th~ duQ'c dang ky
rieng Ie.
Cac thu6c thu ho~c san ph~m duQ'c cung d.p b6i cac chu s6 hfru khac nhau
co th~ nhom vao cling mQt bQ IVD nSu dan vi dang ky co th~ cung cAp dli cac
thong tin thea yeu c§.ucua thu6c thu va san ph~m nay nhu giAyuy quySn cho phep
dang ky tu chu s6 htru va dfr 1i~u chUng minh hi~u nang su d\lng cua cac thu6c
thu nay khi duQ'c Slr d\lng trong be>IVD.
Vi du:
MQt bQ xet nghi~m miSn dich Enzyme (ELISA) cho virus suy giam miSn
dich 6 ngmJi (HIV) co th~ co.chAt chUng, chAt hi~u chu~n va cac dung dich d~m
rua. TAtca thu6c thu va v~t ph~m nay duQ'csu d\lng cling nhau d~ phat hi~n HIV
va vi v~y co th~ 1amQt bQ IVD. Cac thu6c thu va v~t ph~m nay co th~ dugc cung
cAptach nJi d~ thay thS cho bQ IVD do.
 23

SO' d8 phan nhorn cac trang thi~t b] y t~ theo bQ IVD

:45
:44
Khong

21
22
/20
/08
01
c_
uo
Ph
inh
TB

Diroc sir dung ket hop Khong

SY

d~ hOM thanh mot muc

hu

dich du dinh cu th~?

nt
Va
vt_
o c_
hu
hp
bin
t_
sy

Cac thuoc thir va v~t pham

Khong
tuong thich khi duoc su Khong phai
dung nhu mN be>IVD, bQIVD
nhtrng khong bao g6m thiet
·?
b1·

Khong

Khong Tren nhan ghi ra cac

Diroc cung cclpthea ten thu6c thir va vat pham
cua mot b(_)IVD duy nay duoc sir dung
nh~t? cung voi be>IVD?

C6
C6

B(_)IVD
 24

4. H~ thBng

:45
H~ thong trang thi~t bi y t~ bao gom mot s6 trang thi~t bi y t~ va phu kien

:44
hoac cac phu kien k~t h9'P voi nhau thanh mot h~ thong, cac thanh phan trong h~

21
22
thong dap irng cac yeu c~u sau:

/20
/08
- Til mot chu sa hiru;

01
c_
- D\I dinh duoc sir dung k~t h9'P dS dat duoc mot muc dich sir dung chung;
uo
Ph

- Tuong thich khi diroc sir dung nhu mot h~ thong;

inh
TB

- La cac thanh phdn c~u thanh mot h~ thong co ten goi rieng. Truong h9'P h~
SY

thong do khong co ten goi rieng thi m6i thanh ph~n c~u thanh he thong phai duoc
hu
nt

thS hien tren nhan, huang d~n sir dung hoac tai lieu ky thuat trong do co chi dinh
Va

cac bQphan c~u thanh nay se dugc su d\lng cling vai nhau thanh mQt h~ th6ng.
vt_
c_

Cac thi~t bi la mQt bQ ph?n cua h~ th6ng se chi dugc cung c~p dS su dVng
uo
ph

cho h~ th6ng do. TruOng h9'P mQt thi~t bi co thS dugc cung c~p dS su d\lng cho
inh
t_b

nhiSu h~ th6ng thi thi~t bi do phai dugc dang ky cling vai tUng h~ th6ng rieng bi~t
sy

ho~c co thS dugc dang kY rieng Ie.

Chu sa hilu cua h~ th6ng co thS k~t h9'P cac thi~t bi va phv ki~n tir cac chu
sa hilu khac tra thanh mQt bQ ph?n cua h~ th6ng dS d~t dugc mvc dich su d\lng
cua h~ th6ng.
Vi du:
H~ th6ng thea d6i b~nh nhan cua Chu sa hilu A dugc d\I dinh su dVng vai
cac cam bi~n d~u hi~u sinh t6n va d~u do (probes) cua Chu sa hilu B. Cac phv
ki~n nay dugc su d\lng k~t h9'P dS d~t dugc mQt mvc dich su dVng chung thea tieu
chu~n cua Chu sa hilu A, va co thS dugc dang ky cling vai h~ th6ng thea d5i b~nh
nhan trong mQt h6 so.
 25

SO'd8 phan nhom cac trang thi~t hi Y t~ theo h~ thBng

:45
:44
21
Khong

22
/20
/08
01
c_
uo
Ph
inh
TB

Duoc sir dung kSt Khong

SY

hQP dS dat diroc mot

hu
nt

muc dich chung?

Va
vt_
o c_
hu
hp
bin
t_
sy

Tuong thich khi sir

dung nhir mot h~ Khong la h~ thong
thong? trang thiet bi y tS

Khong

Khong
Tren nhan cua m6i
Diroc ban duoi b9 phan c§.uthanh
mot ten h~ thong ghi res ducc sir dung
duy nh§.t? nhu mot h~ thong?

Co
Co

H~ thong trang thiet bi y tS

 26

Vi du v~ nh6m nhieu h¢ thong thanh mot ho:

:45
HQ: h~ thong chinh hinh DMECCH

4
1:4
22
I

02
8/2
H~ thong: H~ thong: H~ thong:

1/0
H~ thong chinh H~ thong chinh H~ thong chinh
0
c_
hinh DMEC CHI hinh DMEC CH2 hinh DMEC CH3
uo
Ph

- Phi~n - Phi~n - Phi~n

inh

- Que - Que - Que

-o,
TB

vit - Oc vit - Oc vit

SY

- Thi~t bi - Thi~t bi - Thi~t bi

hu
nt
Va

Luu y: Cac thanh phan c~u thanh chinh nhu que c~y ghep, phien va 6c vit trong
vt_
c_

cac h~ thong la cac bi~n thS duoc cho phep, Su khac nhau vS dQ dai cua cac 6c
uo
ph

vit c~y ghep cling duoc coi la cac bien thS cho phep.
inh
t_b

- M(jt h¢ thong thay thi xuong hong bao g6m cac bQ phan xuong dui va 6
sy

c6i co thS diroc dang ky nhu mot h~ thong. Cac bQ phan nay phai diroc sir dung
k~t hQ'PdS dat duoc m\lc dich su d\lng chung la thay th~ toan bQxuong hong, kich
thu6c cac bQ ph~n co thS khac nhau.
- M(jt may phdu thu(lt ai¢n va ph1;lki¢n bao g6m k~p, di~n cvc, gia di~n cvc,
day d~n chinh, d~u c~m ph6i hQ'P,khi duQ'csu d\lng cling nhau cho mQt m\lc dich
su d\lng chung, co thS duQ'c dang ky nhu mQt h~ th6ng.
- M(jt b(j d1;lngC1;lagt catheter bao g6m dao, syringe, kim, gang tay ph~u
thu~t, gC;lc,man va dung djch rna, da duQ'cdanh gia tinh tuong thich va duQ'cl~p
rap bai mQt chu sa
hfru du6i mQt ten duy nh~t dS su d\lng k~t hQ'Ptrong quy trinh
d~t catheter ph~u thu~t, co thS duQ'cnhom thanh mQt h~ th6ng.
- Cac may ao huyit ap tI! a(jng co cac tinh nang tliy chQn nhu bQ nh6 va kha
nang in dfr li~u v6i nhiSu model khac nhau co thS duQ'cxem la mQthQh~ th6ng.
5. C1}m trang thi~t bi Y t~ chAn dmin IVD (C1}m IVD)
C\lm IVD bao g6m mQt s6 thu6c thu va san ph~m dS ch~n doan trong 6ng
nghi~m co cling cac thong tin sau:
- DuQ'c cung c~p til cling mQt chu sa hfru;
- Co cling phan 10C;li
rui ro (thuQc 10C;li
A ho~c 10C;li
B);
- ThuQc cling m<)t lOC;lic\lm IVD va mQt phuong phap xet nghi~m thong
thuemg duQ'cli~t ke tC;liBang 2.
C\lm IVD co thS bao g6m cac may phan tich duQ'c thi~t k~ dS su d\lng v6i
thu6c thu trong c\lm IVD.
 27

Bang 2. Danh sach cac phuong phap xet ngbi~m tbuimg g~p va cac loai cum IVD

:45
STT Phuong phap Loai cum Vi du v~ chAt dU'Q'cphan tich

4
1:4
(danh sach dong)

22
02
1 Sinh hoa Enzymes (i) Acid Phosphatase

8/2
(ii) Alpha-Amylase

/0
01
(iii) Creatine Kinase
c_
uo
(iv) Gamma-Glutamyl Transferase
Ph
inh

(v) Lactate Dehydrogenase

TB

(vi) Lipase
SY
hu

2 Chfrt n~n (Substrates) (i) Albumin

t
an

(ii) Bilirubin
V
vt_

(iii) UreaIBlood Urea Nitrogen

_
oc

(iv) Cholesterol
hu
hp

(v) Creatinine
bin
t_

(vi) Glucose
sy

3 Thu6c thir Dien giai (i) Ammonia

4 Dien ClJCDien giai
5 Dien ClJCChfrt n~n/ (i) Dien ClJCCreatinine
6 Mi~n dich
(ii) Bicarbonate
(iii) Calcium
(iv) Chloride
(v) Magnesium
(vi) Phosphate Inorganic/Phosphorus
(i) Dien ClJCAmmonia
(ii) Dien ClJCCarbon Dioxide
(Bicarbonate)
(iii) Dien ClJCCalcium
(iv) Di~n ClJCChloride
(v) Di~n ClJCMagnesium
(vi) Dien ClJCPotassium
B<)cam bien sinh h9C (ii)Di~n ClJCGlucose
(iii) Dien ClJCGlycated Hemoglobin
(iv) Di~n ClJCLactate
(v) Di~n ClJCUrea
(vi) Dien ClJCBilirubin
Globulin mi~n dich (i) Globulin mi~n dich A
(khong co IgE) (ii) Globulin mi~n dich D
(iii) Globulin mi~n dich G
(iv) Globulin mien dich M
(v) B<)xet nghiem c6 dinh mi~n dich
 28

STT Phuong phap Lo~i cum Vi du v~ chit drrQ'cphan tich

:45
(danh sach dong)

:44
21
7 Thanh phfrn B6 sung (i) Thanh phan B6 sung Clq

22
(ii) Thanh phan B6 sung chat bfrt hoat C 1

/20
/08
(iii) Thanh phan B6 sung C3/C3c

01
(iv) Thanh phan B6 sung cho Bb
c_
uo
(v) Thanh phan B6 sung C4
Ph
inh

(vi) Thanh phan B6 sung C5a

TB

8 Protein V~n chuyen (i) Albumin

SY

(ii) Ceruloplasmin
hu
nt

(iii) Haptoglobin
Va
vt_

(iv) Hemopixin
c_
uo

(v) Lactoferrin
ph

(vi) Pre-albumin/Transthyretin
inh
t_b

9 Lipoprotein (i) Apolipoprotein AI

sy

(ii)Apolipoprotein A II
(iii) Apolipoprotein B
(iv) Apolipoprotein E Sub-typing
(v) Lipoprotein (a)
10 Cac Protein f)~c thu (i) a l-Acid Glycoprotein
khac (ii) a l-Antitrypsin
(iii) a l-Microglobulin
(iv) Fibronectin
(v) Immuno Reactive Trypsin
11 Di img (i) Globulin mi~n dich E - T6ng th~
(ii) Globulin mi~n dich E - Sang 19C
(iii) Globulin mien dich E - f)~c hieu,
mot thi nghiem/mot k~t qua
(iv) Chat gay di irng d~c hieu IgA
(v) Chfrt gay di irng d~c hieu IgG
12 Cac dfru frn Ung thu (i) Dfru frn GI CA242
(ii)p53
--
13 Dfru an chirc nang (i) Triiodothyronine TV'do
tuyen giap (ii) Thyroxine TV'do
(iii) Hormone Kich thich Tuyen giap
(iv) T - Uptake
(v) Thyroglobulin
(vi) Neonatal Thyroxine
 29

STT Phuong phap Loai cum Vi du v~ chAt dU'Q'cph in tich

:45
(danh sach dong)

:44
Kha nang sinh san!

21
14 (i) Androstenedione
Hormone thai kyl

22
(ii) Estradiol

0
8/2
Protein
(iii) Prolactin

/0
01
(iv) Placental Lactogen a nguoi
c_
uo
(v) Estriol
Ph
inh

15 Xet nghiern dai thao (i) C-Peptide

TB

dirong (Hormone) (ii) Glucagon

SY

(iii) Insulin
nthu

(iv) Glycosylated/Glycated Haemoglobin

Va
vt_

(v) Islet Cell Ab

c_

(vi) Pro insulin

uo
ph
inh

16 Xet nghiem chuyen (i) Aldosterone

t_b

h6ath~n (ii)Angiotensin I I II
sy

(iii) Enzyme chuyen Angiotensin

(iv) Cortisol
(v)Renine
17 Xet nghiem chuyen (i) Alkaline Phosphatase a xuong
h6a xuong va khoang (ii) Calcitonin
ch~t (iii) Cross-linked C-Telopeptides
(iv) Cross-linkded N- Telopeptides
(v) Cyclic Adenosin Monophosphate
(vi) Hydroxyproline
18 Hormone n9i tiet va (i) Adrenocorticotropic Hormone
Peptide (ii)Hormone tang tnrong a ngiroi
(iii) yeu t5 tang tnrong I giong Insulin
(iv) yeu t5 tang tnrong giong Insulin g~n
voi Protein 1
(v) Vasointestinal Peptide
(vi) Vasopressin
19 x« nghiem chirc (i) Bombesin
than kinh noi (ii) 17-Hydroxy-Ketosterone
(iii) ~-Endorphin
(iv) Neurotensin
(v) Somatostatin
(vi) Substance P
20 Cac Hormone rieng (i) Gastrin
(ii)Hormone giai ph6ng Gonadotropin
 30

STT Phuong phap Loai cum Vi du v~ ch§t dU'Q'cphan tich

:45
(danh sach dong)

:44
(iii) Melatonin

21
22
(iv) Pepsinogen

/20
(v) Adrenalin

/08
01
(vi) Dopamine
c_
uo
21 B~nh thieu mau (i) Erythropoietin
Ph
inh

(ii) Ferritin
TB

(iii) Folate
SY

(iv) S~t
hu
nt

(vj Kha nang mang S~t

Va

(vi) Thu the Transferrin hoa tan

vt_
c_
uo

22 Vitamin (i) Vitamin B 1

ph

(ii) Vitamin B2
inh
t_b

(iii) Vitamin B6
sy

(iv) Vitamin B12

(v) Vitamin D (Cholecalciferol)
(vi) Yeu t6 NOi tai (Chan khang th~)
23 Theo d5i thuoc (i) Caffeine
(ii) Benzodiazepines
(iii) Penicillins
(iv) Tetracyclines
24 Doc chfrt h9C (i) Amphetamines
(ii) Cocaine
(iii) Morphines
(iv) Phencyclidine
(v) Acetaminophen
(vi) Catecholamines
(vii) Ethanol
(viii) Salicylate
25 Cac benh 1\1' miSn dich (i) Khang th~ khang nhan (ANA)
(ii) Anti -topoisomerase
(iii) Khang th~ tv dong cua co quan cu
th~
(iv) Phirc chfrt miSn dich hru thong
(v) Khang th~ thu th~ TSH
(vi) Khang th~ khang Cardiolipin
26 Dfrufin benh viem kh6p (i) Anti-Streptococcal Hyaluronidase
(ii) Anti-Streptokinase
 31

STT Phurmg phap Loai c...m Vi d...v~ ch§t dllq'c phan tich

:45
(danh sach dong)

:44
(iii) Anti-Streptolysin 0

21
22
(iv) C-Reactive Protein

/20
/08
(v) Anti-Staphylolysin

01
(vi) Anti-Streptococcal Screening
c_
uo
27 Chirc nang Gan (i) MEGX
Ph
inh

(ii) Carbohydrate Deficient Transferrin

TB

28 D~u ~n Tim (i) Homocysteine

SY

(ii) ST2
hu
nt

(iii) Galectin-3
Va
vt_

(iv) Myeloperoxidase (MPO)

c_

29 Nhi&n khufut - Mifudich (i) Bacillus subtilis

uo
ph

(ii) Pseudomonas Aeruginosa

inh

(iii) Helicobacter Pylori

t_b
sy

(iv) Lactobacillus casei

30 Nhi&n virus- Mifudich (i) Norovirus
(ii) Rotavirus
(iii) Hantavirus
31 Nhiem ky sinh trung - (i) Leishmania
Mien dich
32 Nhi&n nb - Mifu dich (i) Candida albicans
(ii)Aspergillus
33 Huyet hoc/Me Xet nghiem Hemoglobin (i) Xac dinh Hemoglobin (Hb tong the)
hoc/T~ bao (ii) Oxyhemoglobin phan doan (F02Hb)
hoc (iii) Carboxyhemoglobin phan dean
(~hong bao (FCOHb)
gorn xet (iv) Methemoglobin phan doan
nghiem mau (FMetHb)
d~truyen
(v) Deoxyhemoglobinphan doan (FHHb)
mau)
34 Xet nghiern Dong (i) Thai gian Prothrombin
mau T6ng quat (ii) Thai gian Thrombin
(iv) Thai gian Dong rnau Hoat h6a
(v) Thai gian Thromboplastin M<)tphan
Hoat hoa
35 ck mau (Dong mau) (i) Fibrinogen
(ii) Thu6c thir Protein C va Protein S
(iii) Ch~t ire ch~ C 1
(iv) Alpha-Antiplasmin
(v) Fibrin
(vi) Y~u t6 XIII
 32

STT Phuong phap Lo~i cum Vi dl,l v~ chAt dUQ'c ph an tich

:45
(danh sach dong)

:44
(vi) Yeu to Tieu cau 4

21
22
(vii) Plasminogen

/20
36 Cac xet nghiem huyet (i) Cong thirc mau tong th~

/08
hoc khac

01
(ii) Ty l~ H6ng cc1u
c_
uo
(iii) Ty l~ Lang Hong cau
Ph

37
inh

Cytokine(Lymphokine)/ (i) Interferons

TB

Chat tang cuong (iij Khang nguyen/Thu th~ hoa tan

SY

mien dich (iii) Y~u t6 gay hoai tir khoi u

hu
nt

(iv) Y~u t6 thuc dc1ycum khuan

Va

(vi) Thu th~ cac y~u t6 hoai nr kh6i u

vt_
c_

38 Thu6c thir Mo hoc/ (i) Nhuom H6a t~ bao

uo
ph

T~ bao hoc (ii) Phuong tien nhung, c6 dinh, g~n

inh
t_b

(iii) Dung dich Nhuom

sy

(iv) BQ dung cu h6a rno mien dich

39 Moi tnrong Nuoi c~y (i) Moi tnrong nuoi cay khir mroc (DCM)
(ii) Ch~t phu gia cho DCM
(iii) Moi tnrong chuan bi s&n(Ong, chai,
phien)
(iv) T~ bao, moi truOng, huy~t thanh d~
nuoi cay virus
40 Xet nghi~m Tinh mfrn (i) Xet nghi~m man cam vai
cam Erythromycin cho Staphylococcus aureus
Xet nghi~m tinh mfrn (ii)Xet nghi~m mfrn cam vai Tobramycin
cam Clla vi khucin vm cho Pseudomonas aeruginosa
mQts6 thu6c khang sinh (iii) Xet nghi~m mfrn dim vai vai n~m
41 Dinh danh moi (i) ID Thu cong Gram am
truOng sinh h6a (ID) (ii)ID Thu cong Gram duong
(iii) Cac bQ ID Thu cong khac - Vi khucin
ky' khi, kh6 tinh
42 Dinh danh moi (i) Xet nghi~m TruQ't Phan nh6m Khuc1n
truOng mi~n dich lien cc1u
(ii)Xac dinh ki~u huy~t thanh (E.coli,
Salmonella, Shigella v.v.)
43 Dinh danh moi (i) Streptococci
truOng (ID) dl,l'atren (ii) Shigella
Nucleic Acid (NA)
44 Dinh danh (ID) huy~t (i) Dung cho Ky sinh trung hQc va N~m
thanh hQc (N~m va N~m men)
 33

STT Phuong phap Loai c....m Vi d ....v~ chAt dU'Q'cphan tich

:45
(danh sach dong)

:44
21
45 Nhi€m khufuI (Phat (i) Streptococci

22
hien bang each thuoc (ii) Shigella

/20
thuNA)

/08
01
46
c_
uo Nhiem virus (Phat hien (i) Thu6c thir NA cho Cum va A cum
boi Thu6c thuNA)
Ph
inh

47 Nhiem nam (i) Thu6c thir NA cho Nam

TB

(ii) Nfrm Candida albicans

SY

(iiii) Nam Aspergillus

hu
nt
Va
vt_
o c_
hu
hp
bin
t_
sy
 34

SO'dB phan nhom cac trang thi~t hi y t~ theo cum IVD

:45
:44
21
Khong

22
/20
/08
01
c_
uo
Ph
inh
TB

Khong
SY
hu
nt
Va
vt_
o c_
hu
hp
bin
t_
sy

Thu6c thir va v~t pham

co chung phirong phap
xet nghiem va loai cum Khong la cum IVD
nhir liet ke a
bang tren?

Co

C\lmIVD
 35

NSu thuoc thir hoac vat pham diroc str dung voi nhieu nhorn khac nhau thi

:45
co thS nhom vao nhieu cum IVD khac nhau.

:44
21
Sa d6 vi du vS nhom thuoc cum IVD nhom B co 4 san pham nam trong

22
nhom Cum Enzyme.

/20
/08
Vi du: Chu sa hfru la "DMEC"
01
c_
uo
1 Cum IVD nh6m B
Ph
inh

(Vi du: Enzymes)

TB
SY
hu
nt

I
Va

I I
vt_

~-I
c_

BQ xet nghiem BQ xet nghiern BQ xet nghiem BQ xet nghiem I

uo

enzyme A enzyme B enzyme B enz ymeB

ph

!
DMECABC
inh

DMECABC DMECENZ i DME CENZ

t_b
sy

DVa tren vi du nay, 04 san pham IVD dap irng yeu c~u dS ncp h6 sa la cum
IVD (Cum Enzyme) va ten cac san pham diroc li~t ke tren s6 dang Icy hru hanh
nhu sau:
1. BQ xet nghiem enzyme A * DMEC ABC
2. BQ xet nghiem enzyme B** DMEC ABC
3. BQ xet nghiern enzyme B*** DMEC ENZ
4. BQ xet nghiem enzyme C**** DMEC ENZ
* BQxet nghiem enzyme A DMEC ABC trong do DMEC Ia chu sa hilu san pham
sa
va ABC la ten hCiu.
** BQxet nghiem enzyme B DMEC ABC trong do DMEC la chu sa hiiu san pham
sa
va ABC la ten hiru.
*** BQxet nghiem enzyme B DMEC ENZ trong do DMEC la chu sa hfru san pham
sa
va ENZ la ten hiiu.
****BQxet nghi~menzyme C DMEC ENZ trong do DMEC la chu sa hiiu san phk
sa
va ENZ la ten hfru.
6. BQ trang thi~t bi Y t~ khac
BQ trang thiSt bi y tS khac la mQt t~p hqp g6m hai hay nhiSu trang thiSt bi y
tS khong thuQc lo~i trang thiSt bi y tS ch~n doan in vitro dm;rc dan nhan va cung
c~p trong mQt dan vi dong goi duy nh~t bai mQt chu sa
hfiu, BQ duqc xac dinh:
- Co mQt ten rieng cua bQ;
- Duqc dan nhan va cung c~p trong mQt dan vi dong goi duy nh~t thea quy
dinh cua chu sa hfru san ph~m;
- Co mQt m\lc dich su d\lng chung.
 36

Danh muc cac trang thiSt bi y tS trong bo co thS khac nhau v~ s6 hrong va SlJ
kSt hop cac san pham t<;10thanh bQ da dang ky d6i voi mot dan vi dong goi rna

:45
:44
v~n gifr nguyen ten chu sa hiru cua bQ va muc dich su dung cua bQ.

21
Chu sa hiru bQ phai chiu trach nhiem v~ bQva muc dich sir dung cua no, chu

22
/20
sa hiru bQ co thS kSt hop cac trang thiet bi y tS til cac chu sa hfru khac tro thanh

/08
mot bQ phan cua bQ dS dat duoc mot muc dich sir dung chung. Trong san xu~t va
01
c_
l~p nip be, cac bang clnrng dam bao tinh an toan, ch~t hrong, hieu qua cua bQphai
uo
diroc cung c~p trong h6 sa dang ky, Cac thong tin lien quan phai nQP co thS bao
Ph
inh

g6m S\f ti~t trung, tu6i thQ, b~ng chUng vS vi~c su dVng va tinh tuang thich khi su
TB

dVng la mQt bQ,h~ th6ng quan ly ch~t lugng, ... Nhan mac, cv thS la tai li~u huang
SY

d~n su dVng, nSu co phai neu r5 mvc dich su dVng chung cua bQ.
thu

Cac thiSt bi y tS dugc dang kY thuQc mQt bQphai dugc dang ky trang thiSt bi
an
t_V

y tS dan Ie truac khi lUll hanh nhu mQt trang thiSt bi y tS rieng Ie vai ml,lcdich Slr
_v

dl,lngrieng cua no ho~c dS thay thS.

u oc
ph

NSu mQt trang thiSt bi y tS trong mQt bQ dugc cung c~p dS Slr dVng cho mQt
inh

bQ khac, trang thiSt bi y tS do phai dugc dua vao h6 sa dang kY lUll hanh cua bQ
t_b
sy

khac do.
Ten bQ phai xu~t hi~n tren nhan san phftm g~n tren bao bi ben ngoai cua bQ,
danh ml,lc cac trang thiSt bi y tS co trong bQ phai dugc ghi tren bao bi ngoai cua
bQ ho~c tai li~u di kern. Khong yeu c~u phai ghi ten cua bQ tren nhan cua tUng
trang thiSt bi y tS trong bQ.
Vi du:
- MQtbQClmthuang bao g6m cac thiSt bi y tS nhu bang, g<;1C,man va nhi~t kS,
khi dugc dong goi cilng nhau trong mQt dan vi dong goi duy nh~t cho mQt mvc dich
y khoa chung bai mQt chu sa hfru san phAm,co thS dugc dang kY nhu mQtbQ.
- MQt chu sa hfru cung c~p khay d6 bang bo tily chinh vai s6 lugng va 10<;1i
g<;1C
va chi khau khac nhau cho cac b~nh vi~n khac nhau. Khi t~t ca cac trang thiSt
bi y tS trong bQ da dugc dang ky, chu sa hfru co thS tily chinh cac trang thiSt bi
trong bQ cho cac b~nh vi~n khac, trong khi v~n gifr nguyen ten bQ va ml,lcdich su
dVng da dang kY. Nhan cua khay phai li~t ke danh mvc cac trang thiSt bi y tS dugc
cung c~p trong khay. MQt s6 trang thiSt bi y tS trong bQ co thS dugc dong goi va
dan nhan rieng, trong khi cac thiSt bi khac a d<;1ng
khong dugc dong goi va co thS
khong dugc dan nhan.
- D<;1ngdong goi khuySn mai ho~c dong goi ti~n dVng, rna khong co ten bQ
va khong co mvc dich y khoa chung, bao g6m s6 lugng khac nhau cua cac thiSt
bi y tS. Vi dV: dung dich da dVng, dung dich nuac mU6i sinh ly, va hQP kinh ap
trang, se khong du diSu ki~n dS dang kY la mQt bQ, phai dang ky tUng trang thiet
bi y tS trong do nhu cac trang thiSt bi y tS dan Ie.
 37

SO'dB phan nhom cac trang thi~t b] y t~ theo b{}

5
4:4
1:4
22
02
8/2
Tap hop cua

1/0
hai hay nhieu
_0
uoc trang thiet bi?
Ph
nh
Bi
T
SY
thu

Khong
an
t_V

Co mot ten
v
c_

rieng cua bo?

uo
ph
inh
t_b
sy

Khong
Diroc ?an nhan va
cung cap trong mot
bao bi dong goi boi
chu so htru?

Khong
Khong la b9 trang thiet bi y tS

Co
B9 trang thiSt bi y tS
 38

PhI} luc II

:45
(Ban hanh kern thea Thong tu s6 05 120221TT-BYT ngay 01 thong 8 ndm 2022

4
1:4
cua Btl truong Btl Y Ii)

22
02
8/2
1/0
TEN COSO CONG HoA xA HOI CHU NGHiA VI:E:TNAM
_0
oc
u
DQc l~p - T1}'do - Hanh phuc
Ph
inh

S6: ...... ' .... t hang

I , ngay
...... ' ..... nam
~ 20...
B
S YT

BAN KET QuA PHAN LO~I TRANG THIET BJ Y TE

hu
nt
Va
vt_

Can cir Nghi dinh s6 98/2021IND-CP ngay 08 thang 11 nam 2021 cua Chinh
c_

phu vS quan ly trang thiet bi y tS;

uo
ph
inh

Can cir Thong ill s6 /2022/TT-BYT ngay thang 8 nam 2022 cua B(>tnrong
t_b

B(>Y tS quy dinh ehi tiSt thi hanh mot s6 diSu cua Nghi dinh s6 98/20211ND-CP
sy

ngay 08 thang 11 nam 2021 cua Chinh phu vS quan ly trang thiSt bi y tS;
Chung toi phan loai trang thiSt bi y tS nhu sau:
Ten Hang, Hang, M1}cdich Can crr d~ Mrrc dQ rui
Chung
trang nurrc nurrc sfr dung theo phan loai ro drrQ'c
TT lo~i/ rna
thi~t b] san chu sO' chi djnh cua mire dQ phan loai
san pharn
y t~ xn§t hii'n chu sO'hfru rui ro

Ngufri d~i di~n hQ'P phap cua coosO'

th1}'chi~n phan lo~i
(Ky ten, ghi h9 ten ady au, chuc danh)
Xac nh{Jn bdng ddu hoi;icchi( kY s6

I Via danh